Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 16
- Latest Decision
- 2025-02-10
Clearances · page 3 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K243511 | OTC TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | NGX | Class II | 2025-02-10 |
| K243488 | VMAT PRO | Termosalud | ISA | Class I | 2025-02-06 |
| K241488 | TrainFES Advance | Trainfes | IPF | Class II | 2025-02-05 |
| K242982 | Mobility Scooter (MS160A) | Suzhou Master Machinery Manufacturing Co.,Ltd | INI | Class II | 2025-01-31 |
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | Avanos Medical, Inc. | IRP | Class II | 2025-01-31 |
| K241193 | AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) | Marzzan Lucas Jorge | JFB | Class II | 2025-01-31 |
| K243442 | iBOT® PMD | Mobius Mobility | IMK | Class II | 2025-01-30 |
| K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | NHN | Class II | 2025-01-24 |
| K242714 | Mobility Scooter (S-01); Mobility Scooter (S-02) | Zhejiang Seedream Medical Equipment Co., Ltd. | INI | Class II | 2025-01-23 |
| K233770 | Pepper EMS Training System | Pepper Interactive, Inc. | NGX | Class II | 2025-01-16 |
| K243791 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | IRP | Class II | 2025-01-13 |
| K241641 | Electric Wheelchair (YE200) | Shenzhen Yattll Industry Co., Ltd. | ITI | Class II | 2025-01-11 |
| K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | IOR | Class I | 2025-01-10 |
| K240267 | Klaxon (Twist); Klaxon (Twist R) | Klaxon Mobility GmbH | ITI | Class II | 2025-01-10 |
| K240590 | Electrical Scooter, WT-T4SU | W'U'S Tech Co., Ltd. | INI | Class II | 2025-01-08 |
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) | Ceragem Co., Ltd. | JFB | Class II | 2025-01-08 |
| K242139 | Mobility Scooter (YL-09B, YL-07) | Yongkang Yile Vehicle Co., Ltd. | INI | Class II | 2025-01-06 |
| K242760 | WHILL Model R | Whill, Inc. | INI | Class II | 2025-01-06 |
| K242448 | Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) | Anhui Jbh Medical Apparatus Co., Ltd. | ITI | Class II | 2025-01-02 |
| K242989 | Electric Wheelchair (MODEL H) | Nanjing E-Take Medical Apparatus Co., Ltd. | ITI | Class II | 2024-12-31 |
| K242468 | Power Wheelchair (D10, D12, D15, D17, D20, D37) | Anhui Jbh Medical Apparatus Co., Ltd. | ITI | Class II | 2024-12-31 |
| K242252 | Power Wheelchair | Anhui Jbh Medical Apparatus Co., Ltd. | ITI | Class II | 2024-12-27 |
| K243177 | SACS PRO | Elastimed , Ltd. | IRP | Class II | 2024-12-23 |
| K242628 | Scooter (PS30) | Lichtmega Technology Co., Ltd. | INI | Class II | 2024-12-20 |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | IPF | Class II | 2024-12-19 |
| K232813 | Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda | NHN | Class II | 2024-12-19 |
| DEN240014 | ARC-EX System | Onward Medical, Inc. | SDO | Class II | 2024-12-19 |
| K243440 | Electric Wheelchair (HC820N) | Yongkang Hengyi Vehicle Co., Ltd. | ITI | Class II | 2024-12-19 |
| K242787 | Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd. | NGX | Class II | 2024-12-18 |
| K241395 | Active System; Avenue8 | Caerus Corporation | ILX | Class II | 2024-12-18 |
| K242747 | FAQ (302) | Foreo, Inc. | OAP | Class II | 2024-12-11 |
| K242327 | Empulse M90 | Concourse Assistive Technology Pty, Ltd. | ITI | Class II | 2024-12-10 |
| K242619 | GroWell BT Hair Growth System (GW10042) | Apira Science, Inc. | OAP | Class II | 2024-12-02 |
| K242308 | Power wheelchair | Zhejiang Zhonglei Medical Technology Co. , Ltd. | ITI | Class II | 2024-11-27 |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902) | Ceragem Co., Ltd. | JFB | Class II | 2024-11-27 |
| K241588 | Electric Wheelchair (KR8803) | Zhejiang Kairui Medical Device Co., Ltd. | ITI | Class II | 2024-11-25 |
| K232982 | EMS Sculpt Machine | Shandong Huamei Technology Co., Ltd. | NGX | Class II | 2024-11-25 |
| K242722 | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | IOR | Class I | 2024-11-22 |
| K241529 | Powered Wheelchair (NXN20-209) | Zhejiang Nysin Medical Co., Ltd. | ITI | Class II | 2024-11-22 |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OAP | Class II | 2024-11-20 |
| K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. | IRP | Class II | 2024-11-20 |
| K241603 | Powered Wheelchair (NXN20-208, NXN20-211) | Zhejiang Nysin Medical Co., Ltd. | ITI | Class II | 2024-11-20 |
| K243320 | Air Pressure Therapy System (VU-IPC04B) | Xiamen Weiyou Intelligent Technology Co., Ltd. | IRP | Class II | 2024-11-18 |
| K242402 | Power wheelchair | Zhejiang Zhonglei Medical Technology Co. , Ltd. | ITI | Class II | 2024-11-18 |
| K242471 | Power Wheelchair (W5538) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2024-11-18 |
| K242940 | Xrecovery (XR-001) | Shenzhen Xinrun Electric Appliances Co, Ltd. | IRP | Class II | 2024-11-14 |
| K242791 | Electric wheelchair (KR-8807) | Zhejiang Kairui Medical Device Co., Ltd. | ITI | Class II | 2024-11-12 |
| K242430 | Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) | Soul Mobility | ITI | Class II | 2024-11-12 |
| K241342 | Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. | OAP | Class II | 2024-11-08 |
| K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. | OAP | Class II | 2024-11-01 |
| K241189 | Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) | Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd. | ITI | Class II | 2024-10-29 |
| K242560 | Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co., Ltd. | IOR | Class I | 2024-10-24 |
| K241337 | Electrically powered wheelchair (HP202) | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | 2024-10-17 |
| K241267 | Hidroxa SE30 | Hidroxa Medical AB | EGJ | Class II | 2024-10-17 |
| K241632 | Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | 2024-10-16 |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. | ILY | Class II | 2024-10-15 |
| K240472 | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. | OAP | Class II | 2024-10-11 |
| K242387 | Mobility Scooter (N3473) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2024-10-11 |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | IPF | Class II | 2024-10-10 |
| K240563 | Power Wheelchair (JJW-6001) | ZheJiang J&J Mobility Co., Ltd. | ITI | Class II | 2024-10-08 |
| K241446 | Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) | Sichuan Qianii-Beoka Medical Technoiogy Lnc. | IRP | Class II | 2024-10-08 |
| K240843 | GENESIS (MS-P02-GEN) | Climbing Steps, Inc. | ILK | Class II | 2024-10-07 |
| K241854 | Power Wheelchair | Anhui Jbh Medical Apparatus Co., Ltd. | ITI | Class II | 2024-10-04 |
| K240331 | Electric wheelchair (YHWL002, YHWL003) | Yongkang Youha Electric Appliance Co., Ltd. | ITI | Class II | 2024-10-01 |
| K240689 | Robin's Egg | Telebrands Corporation | OAP | Class II | 2024-09-17 |
| K242186 | Neo Sculptor (OF-NEO001) | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | NGX | Class II | 2024-09-17 |
| K240373 | Air compression Leg Massager (MM0520, MM0521, MM0522) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | IRP | Class II | 2024-09-17 |
| K241379 | Powered Wheelchair (NXN20-205, NXN20-205M) | Zhejiang Nysin Medical Co., Ltd. | ITI | Class II | 2024-09-16 |
| K240638 | Power Wheelchair (YH-E7007) | Ningbo Youhuan Automation Technology Co., Ltd. | ITI | Class II | 2024-09-16 |
| K242441 | Revian Lyte (10011) | Revian, Inc. | OAP | Class II | 2024-09-13 |
| K242136 | Electric wheelchair (C001) | Zhejiang Hfizer Medical Equipment Co., Ltd. | ITI | Class II | 2024-09-12 |
| K240168 | N7-S | Nuga Medical Co., Ltd. | JFB | Class II | 2024-09-12 |
| K240990 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2024-09-10 |
| K241723 | Electric wheelchair (W3902) | Zhejiang Richall Medical Technology Co., Ltd. | ITI | Class II | 2024-09-05 |
| K241721 | Electric wheelchair (N3901) | Zhejiang Richall Medical Technology Co., Ltd. | ITI | Class II | 2024-09-05 |
| K232692 | Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) | Intradin (Shanghai) Machinery Co., Ltd. | INI | Class II | 2024-09-05 |
| K241256 | JetBoots PRO Plus | Therabody, Inc. | IRP | Class II | 2024-08-30 |
| K240105 | Navigator (FMNVG15); Navigator XL (FMNVX06) | Forcemech International, LLC | ITI | Class II | 2024-08-29 |
| K240270 | Electric wheelchair (S7018) | Guangdong Prestige Technology Company Limited | ITI | Class II | 2024-08-27 |
| K240234 | BTL-899MS | BTL Industries, Inc. | IPF | Class II | 2024-08-17 |
| K241686 | Power wheelchair (N6101) | Zhejiang Zhonglei Medical Technology Co. , Ltd. | ITI | Class II | 2024-08-13 |
| K240079 | Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) | Suzhou Ideal Medical Co., Ltd. | ITI | Class II | 2024-08-09 |
| K240255 | Electric Wheelchair (JLE-W01A-2023) | Zhejiang Jianrui Technology Company Limited | ITI | Class II | 2024-08-07 |
| K241685 | SofWave System | Sofwave Medical, Ltd. | NGX | Class II | 2024-08-07 |
| K240981 | Air compression leg massager | Huizhou Xinyi Technology Co., Ltd. | IRP | Class II | 2024-08-02 |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | IPF | Class II | 2024-08-02 |
| K240339 | Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08) | Shanghai Bangbang Robotics Co., Ltd. | ITI | Class II | 2024-07-22 |
| K240347 | PTG-05 | Zimmer Medizinsysteme GmbH | NGX | Class II | 2024-07-21 |
| K241463 | Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) | Suzhou Master Machinery Manufacturing Co.,Ltd | ITI | Class II | 2024-07-18 |
| K240272 | Electric Scooter (M2085, S2091) | Guangdong Prestige Technology Co., Ltd. | INI | Class II | 2024-07-16 |
| K241460 | Manual Wheelchair | Lichtmega Technology Co., Ltd. | IOR | Class I | 2024-07-11 |
| K240120 | Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. | IOR | Class I | 2024-07-05 |
| K241154 | Electric Wheelchair (YFWB-63) | If Health (Xiamen) Intelligent Technology Co.,Ltd | ITI | Class II | 2024-06-28 |
| K240673 | Electric wheelchair | Zhejiang Hfizer Medical Equipment Co., Ltd. | ITI | Class II | 2024-06-20 |
| K233238 | Air Pressure Therapy System (Model:VU-IPC4M) | Xiamen Weiyou Intelligent Technology Co., Ltd. | IRP | Class II | 2024-06-14 |
| K240008 | Mobility Scooter (W3331) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2024-06-05 |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | ISA | Class I | 2024-06-05 |
| K240913 | Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E) | Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd | ITI | Class II | 2024-05-31 |
| K240456 | Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap | Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC | OAP | Class II | 2024-05-22 |
| K230711 | Pain Therapy Device(Model: P.T.S-X) | Guangzhou Xinbo Electronic Co., Ltd. | NGX | Class II | 2024-05-16 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.