Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 24
- Latest Decision
- 2026-01-16
Clearances · page 2 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH | NGX | Class II | 2026-01-16 |
| DEN250005 | Sana Device | Sana Health | QYN | Class I | 2026-01-16 |
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) | Shanghai Bangbang Robotics Co., Ltd. | ITI | Class II | 2026-01-15 |
| K251458 | Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. | ITI | Class II | 2026-01-15 |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | IOR | Class I | 2026-01-12 |
| K253075 | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | INI | Class II | 2026-01-09 |
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | INI | Class II | 2026-01-02 |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) | Light Tree Ventures Europe B.V. | OAP | Class II | 2025-12-24 |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | INI | Class II | 2025-12-23 |
| K251159 | Power wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. | ITI | Class II | 2025-12-22 |
| K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | NHN | Class II | 2025-12-12 |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | NGX | Class II | 2025-12-09 |
| K252862 | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. | ITI | Class II | 2025-12-08 |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | IOR | Class I | 2025-12-05 |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | IOR | Class I | 2025-12-05 |
| K252494 | Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co., Ltd. | ITI | Class II | 2025-12-05 |
| K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | INI | Class II | 2025-12-04 |
| K250896 | Aura Wave | Aura Wellness, LLC | SGT | Class II | 2025-12-02 |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | IOR | Class I | 2025-11-21 |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | INI | Class II | 2025-11-21 |
| K251821 | ARC-EX System | Onward Medical, Inc. | SDO | Class II | 2025-11-14 |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) | Shenzhen Future Electronic Co., Ltd. | IRP | Class II | 2025-11-13 |
| K252829 | Powered Wheelchair (PL001-9001) | Suzhou KD Intelligent Device Co., Ltd. | ITI | Class II | 2025-11-12 |
| K250819 | Electric Wheelchair (Rollz Motion Electric 2M) | Rollz International BV | ITI | Class II | 2025-11-07 |
| K253478 | Motive Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | NGX | Class II | 2025-11-06 |
| K250376 | ViVY | Viatherm Therapeutics, LLC | IMJ | Class II | 2025-11-05 |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | IOR | Class I | 2025-11-04 |
| K252671 | Electric wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. | ITI | Class II | 2025-11-03 |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OAP | Class II | 2025-10-30 |
| K251531 | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | IRP | Class II | 2025-10-30 |
| K250904 | Atalante X | Wandercraft SAS | PHL | Class II | 2025-10-24 |
| K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | IRP | Class II | 2025-10-24 |
| K252325 | Hair Growth Laser Cap | Cosmo Far East Technology Limited | OAP | Class II | 2025-10-22 |
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | IMG | Class II | 2025-10-07 |
| K252502 | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. | INI | Class II | 2025-10-06 |
| K251565 | Wheelchair (N817) | Zhejiang Topwe Tools Manufacturing Co.,Ltd | ITI | Class II | 2025-10-06 |
| K252517 | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | IOR | Class I | 2025-10-03 |
| K251799 | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) | Jiangsu Bangbang Intelligent Technology Co., Ltd. | INI | Class II | 2025-09-30 |
| K252428 | Electric Wheelchair (Model P2) | Superpi Robot Co., Ltd. | ITI | Class II | 2025-09-18 |
| K251905 | Normatec Elite Hip | NormaTec Industries, LP | IRP | Class II | 2025-09-18 |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | Shenzhen Yicai Health Technology Co., Ltd. | IRP | Class II | 2025-09-17 |
| K251083 | Compact II | Enraf-Nonius, B.V. | IPF | Class II | 2025-09-12 |
| K250047 | bite away two | mibeTec GmbH | IRT | Class II | 2025-09-12 |
| K251891 | Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. | ITI | Class II | 2025-09-09 |
| K251594 | truFlex | Syrma Johari Medtech Limited | NGX | Class II | 2025-08-28 |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | NGX | Class II | 2025-07-30 |
| K250244 | Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. | IRP | Class II | 2025-07-25 |
| K242615 | Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) | Xiamen Taotao Technology Co., Ltd. | IRP | Class II | 2025-07-23 |
| K251638 | Mobility Scooter (MS160C) | Suzhou Master Machinery Manufacturing Co.,Ltd | INI | Class II | 2025-07-22 |
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | ITH | Class II | 2025-07-18 |
| K251378 | CoolTone | Zimmer Medizinsysteme GmbH | NGX | Class II | 2025-07-14 |
| K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401) | Ceragem Co., Ltd. | JFB | Class II | 2025-07-11 |
| K251285 | Electric Wheelchair (HG-630) | Zhejiang Automwheel Tech Co., Ltd. | ITI | Class II | 2025-07-02 |
| K250729 | Power Wheelchair (MOB1107) | Vive Health, LLC | ITI | Class II | 2025-07-02 |
| K251746 | Pure Impact | Sofwave Medical, Ltd. | NGX | Class II | 2025-07-02 |
| K243112 | Curapuls 670 | Enraf-Nonius, B.V. | IMJ | Class II | 2025-06-25 |
| K251606 | Power Wheelchair (D26) | Anhui Jbh Medical Apparatus Co., Ltd. | ITI | Class II | 2025-06-25 |
| K251570 | Hippocampe Marathon and Trail | Vipamat Sarl | IQC | Class II | 2025-06-23 |
| K251248 | ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) | Jinhua Qidian Vehicle Co., Ltd. | ITI | Class II | 2025-06-20 |
| K243102 | Mobility Scooter (JT10) | Jiangxi Jiangte Electric Vehicle Co., Ltd. | INI | Class II | 2025-06-18 |
| K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC | ITH | Class II | 2025-06-18 |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OAP | Class II | 2025-06-17 |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | NGX | Class II | 2025-06-13 |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK) | Shenzhen Idea Light Limited | OAP | Class II | 2025-06-05 |
| K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | IMI | Class II | 2025-06-04 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | IPF | Class II | 2025-06-04 |
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | NGX | Class II | 2025-05-30 |
| K250475 | Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) | Ningbo Baichen Medical Devices Co., Ltd. | ITI | Class II | 2025-05-27 |
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company , Ltd. | ILY | Class II | 2025-05-19 |
| K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | NGX | Class II | 2025-05-19 |
| K243165 | Limfa Therapy System (Limfa Therapy) | Eywa Srl | NGX | Class II | 2025-05-15 |
| K250533 | Magnesium alloy scooter (RS100) | Taizhou Reach Technology Co., Ltd. | INI | Class II | 2025-05-14 |
| K250758 | Electric Wheelchair (F309) | Changshu Pingfang Wheelchair Co., Ltd. | ITI | Class II | 2025-05-09 |
| K243290 | BTL-785MJ | BTL Industries, Inc. | NUW | Class II | 2025-05-09 |
| K243110 | eFOLDi Navigator Powerchair (STPC-A) | Suntech UK , Ltd. | ITI | Class II | 2025-05-08 |
| K242975 | Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. | INI | Class II | 2025-05-07 |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. | IRP | Class II | 2025-05-05 |
| K250308 | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) | Dongguan Boyuan Intelligent Technology Co.,Ltd | OAP | Class II | 2025-04-29 |
| K250158 | Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) | Zhe Jiang Cleisman Industry and Trade Co.,Ltd | ITI | Class II | 2025-04-28 |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Shenzhen Urion Technology Co., Ltd. | IRP | Class II | 2025-04-25 |
| K250146 | SofWave System | Sofwave Medical, Ltd. | NGX | Class II | 2025-04-18 |
| K250748 | KLAXON (TWIST); KLAXON (TWIST R) | Klaxon-Mobility GmbH | ITI | Class II | 2025-04-11 |
| DEN240021 | Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)) | Active Protective Technologies, Inc. | SEC | Class II | 2025-04-09 |
| K250366 | Electric Wheelchair (LW01301A07) | Anhui Longway Medical Technology Co., Ltd. | ITI | Class II | 2025-04-08 |
| K242358 | Powered wheelchair (mobility robot) (M4, M4U) | Xsto Co., Ltd. | ITI | Class II | 2025-04-03 |
| K242041 | STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. | EGJ | Class II | 2025-04-01 |
| K244003 | Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | 2025-03-26 |
| K250134 | Power Wheelchair (YH-E6011,YH-E6013A) | Ningbo Youhuan Automation Technology Co., Ltd. | ITI | Class II | 2025-03-26 |
| K242140 | Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. | IRP | Class II | 2025-03-17 |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | NGX | Class II | 2025-03-12 |
| K243783 | Walking rehabilitation training electric wheelchair (ZW518) | Shenzhen Zuowei Technology Co., Ltd. | IPL | Class II | 2025-03-12 |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward | PHL | Class II | 2025-03-12 |
| K243970 | Portable Wheelchair | Intradin (Shanghai) Machinery Co., Ltd. | ITI | Class II | 2025-03-07 |
| K241159 | Handbike Batec Electric | Batec Mobility, S.L. | ITI | Class II | 2025-03-07 |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. | IOR | Class I | 2025-02-28 |
| K241601 | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | NGX | Class II | 2025-02-25 |
| K250027 | Powered Mobility Scooter | Intradin (Shanghai) Machinery Co., Ltd. | INI | Class II | 2025-02-21 |
| K243206 | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) | Sichuan Qianli-Beoka Medical Technology, Inc. | IRP | Class II | 2025-02-19 |
| K243961 | Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | 2025-02-12 |
| K243962 | Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | 2025-02-12 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.