Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 20
- Latest Decision
- 2023-01-17
Clearances · page 5 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek, LLC | IPF | Class II | 2023-01-17 |
| K222711 | HS186B Scooter | Suzhou Master Machinery Manufacturing Co.,Ltd | INI | Class II | 2023-01-09 |
| K221859 | Atalante | Wandercraft SAS | PHL | Class II | 2022-12-29 |
| K222924 | Leg Massager RF-ALM070 | Shenzhen Ruiyi Business Technology Co., Ltd. | IRP | Class II | 2022-12-23 |
| K222949 | Air Compression Leg Massager (Model: LY-670D) | Zhejiang Luyao Electronics Technology Co., Ltd. | IRP | Class II | 2022-12-22 |
| K222502 | KLICK (VARIANTS: POWER, RACE, MONSTER) | Klaxon Mobility GmbH | ITI | Class II | 2022-12-16 |
| K221862 | YY-A02-B Overlapped Compression Therapy | Huizhou Xinyi Technology Co., Ltd. | IRP | Class II | 2022-12-08 |
| K222669 | Cryopush Cold Compression Device | Chengdu Cryo-Push Medical Technology Co.,Ltd | IRP | Class II | 2022-12-05 |
| K212866 | truSculpt flex | Johari Digital Healthcare Limited | NGX | Class II | 2022-12-03 |
| K221210 | PainShield MD PLUS | Nanovibronix, Inc. | PFW | Class II | 2022-11-23 |
| K222477 | Hair Growth Device | Dongguan Lescolton Medical Equipment Co., Ltd. | OAP | Class II | 2022-11-18 |
| K222364 | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) | Xtrallux, LLC | OAP | Class II | 2022-11-16 |
| K223164 | Aquilo Sports CCT1500 System | Aquilo Sports, LLC | IRP | Class II | 2022-11-04 |
| K221435 | SUPERTILT PLUS (STP) | Power Plus Mobility | IOR | Class I | 2022-10-28 |
| K222201 | Biological Feedback and Stimulation System | Medlander Medical Technology, Inc. | IPF | Class II | 2022-10-21 |
| K221958 | Flex-MI | Emsi, Inc. | IPF | Class II | 2022-10-21 |
| K222495 | Mobility Scooter, Model: W3331F | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2022-10-17 |
| K220994 | Shoulder PacemakerTM | Ncs Lab Srl | IPF | Class II | 2022-10-14 |
| K213748 | CoreLevee | Lutronic Corporation | NGX | Class II | 2022-10-14 |
| K222081 | ID-510 iRestore Elite | Freedom Laser Therapy, Inc. | OAP | Class II | 2022-10-13 |
| K220227 | Auto Folding Scooter, S21F | Heartway Medical Products Co., Ltd. | INI | Class II | 2022-10-12 |
| K213120 | OW100S (model OW100S-US) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | ISA | Class I | 2022-10-12 |
| K221498 | Miha Bodytec II | Miha Bodytec GmbH | NGX | Class II | 2022-10-07 |
| K221154 | Infant Heel WarmerTM; Heel Snuggler® | International Biomedical | MPO | Class I | 2022-10-07 |
| K220156 | Electrically Powered Wheelchair, Joy Rider | Tung Keng Enterprise Co., Ltd. | ITI | Class II | 2022-10-07 |
| K221653 | InfaTherm Disposable Infant Warming Mattress | International Biomedical | IMD | Class I | 2022-10-06 |
| K222206 | Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) | Shenzhen Dongjilian Medical Tech Co., Ltd. | IRP | Class II | 2022-09-30 |
| K221799 | Electric Wheelchair, Model: 9000N | Silver Fox Corporation Limited | ITI | Class II | 2022-09-16 |
| K212189 | FibroLux | Multi Radiance Medical | NHN | Class II | 2022-09-02 |
| K221987 | Erchonia GVL | Erchonia Corporation | NHN | Class II | 2022-09-01 |
| K221189 | OLIZ LTB-1000A | Ltbio Co., Ltd. | ILY | Class II | 2022-08-29 |
| K211298 | WiEMSpro | Medical Cables S.L. | NGX | Class II | 2022-08-25 |
| K201730 | Powered Inflatable Tube Massager - SLIM UP DRAIN | Foggiare Technologies, LLC | IRP | Class II | 2022-08-22 |
| K213524 | CytonPro-5000 | Cytonsys, Inc. | ILY | Class II | 2022-08-10 |
| K220671 | Manual Wheelchair | Hebei Ruilangde Medical Equipment Technology Group Co., Ltd. | IOR | Class I | 2022-07-21 |
| K221666 | Normatec Go | NormaTec Industries, LP | IRP | Class II | 2022-07-14 |
| K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | ISA | Class I | 2022-07-11 |
| K220827 | Electric Wheelchair | Foshan Dahao Medical Technology Co., Ltd. | ITI | Class II | 2022-07-05 |
| K221026 | Power Wheelchair | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2022-07-01 |
| K200715 | RoughRider Aurora Manual Wheelchair | Roughrider America, LLC | IOR | Class I | 2022-06-24 |
| K213789 | Intelligence LaserComb | Yibin Yingtong Intelligent Technology Co., Ltd. | OAP | Class II | 2022-06-24 |
| K220514 | bite away neo | mibeTec GmbH | IRT | Class II | 2022-06-23 |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | Ceragem Co., Ltd. | JFB | Class II | 2022-06-17 |
| K213197 | MyOnyx System | Thought Technology , Ltd. | IPF | Class II | 2022-06-17 |
| K213097 | Armory Motion | Pain Management Technologies, Inc. | ILO | Class II | 2022-06-10 |
| K220988 | EksoNR | Ekso Bionics, Inc. | PHL | Class II | 2022-06-09 |
| K221438 | WHILL Model F | Whill, Inc. | ITI | Class II | 2022-06-07 |
| K213027 | Laser Hair Growth Comb | Kam Yuen Plastic Products , Ltd. | OAP | Class II | 2022-05-26 |
| K212413 | I-Motion | I-Motion Group Global Iberica S.L. | NGX | Class II | 2022-05-26 |
| K221215 | e-motion M25 | Alber GmbH | ITI | Class II | 2022-05-24 |
| K213025 | Laser hair growth helmet | Kam Yuen Plastic Products , Ltd. | OAP | Class II | 2022-05-12 |
| K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2022-05-12 |
| K220747 | Power Wheelchair (N5515B) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2022-05-12 |
| K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | IPF | Class II | 2022-05-12 |
| K212092 | Portable Folding Electric Wheelchair (Model: DC01) | Anhui Jbh Medical Apparatus Co., Ltd. | ITI | Class II | 2022-05-06 |
| K210284 | ManaSport | Manamed, Inc. | IMI | Class II | 2022-04-26 |
| K212090 | Electric Scooter | Anhui Jbh Medical Apparatus Co., Ltd. | INI | Class II | 2022-04-22 |
| K213452 | GEMS-H | Samsung Electronics Co., Ltd. | PHL | Class II | 2022-04-21 |
| K220543 | Auxo A300, A150 and APod | Auxo Hair, LLC | OAP | Class II | 2022-04-20 |
| K220601 | CoolTone | Zimmer Medizinsysteme GmbH | NGX | Class II | 2022-04-01 |
| K213745 | Air Compression Therapy Device, model: ST-502 | Shenzhen Future Electronic Co., Ltd. | IRP | Class II | 2022-03-31 |
| K220213 | Empulse R90 | Sunrise Medical (Us), LLC | ITI | Class II | 2022-03-30 |
| K220207 | Mobility Scooter, Model W3468 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2022-03-24 |
| K220206 | Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2022-03-24 |
| K220529 | Merits P335 Powered Wheelchair | Merits Health Products Co., Ltd. | ITI | Class II | 2022-03-18 |
| K213790 | Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 | Mobility Source Medical Technology Co., Ltd. | IOR | Class I | 2022-03-14 |
| K220327 | geko W-3 | Firstkind Limited | IPF | Class II | 2022-03-04 |
| K211919 | KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat | Kinetic Innovative Seating System, LLC | KNN | Class I | 2022-03-04 |
| K211850 | Air Compression Leg Massager (model: FE-7204B) | Xiamen Healthpal Electronic Co.,Ltd | IRP | Class II | 2022-03-03 |
| K213043 | Levator Elite (Model LE9011) | Shenzhen Dongdixin Technology Co., Ltd. | IPF | Class II | 2022-02-25 |
| K220217 | Normatec 3 | NormaTec Industries, LP | IRP | Class II | 2022-02-25 |
| K212935 | Air Pressure Foot Massager | Xiamen Simo Electronic Co., Ltd. | IRP | Class II | 2022-02-19 |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | Bio Compression Systems, Inc. | IRP | Class II | 2022-02-16 |
| K203337 | PainTB, PainTJ | Ptech Co., Ltd. | NHN | Class II | 2022-02-11 |
| K202728 | Action Trackchair Hawk | Action Manufacturing, Inc. | IPL | Class II | 2022-02-10 |
| K191105 | e-Throne Folding Wheelchair, Model: ET-12F22 | Golden Motor Technology Co., Ltd. | ITI | Class II | 2022-01-21 |
| K203761 | ParaMotion | Powerbasetec GmbH | IPL | Class II | 2022-01-21 |
| K213447 | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. | Shenzhen Cosbeauty Technology Co., Ltd. | OAP | Class II | 2022-01-19 |
| K212503 | HP458E Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | 2022-01-18 |
| K212713 | Air compression leg massager HY-1117A | Xiamen High Top Electronic Technology Co., Ltd. | IRP | Class II | 2022-01-18 |
| K191356 | i3 Foldable Mobility Scooter | Puc Perfect Union Co., Ltd. | INI | Class II | 2022-01-11 |
| K212854 | Powered Wheelchair | Zhejiang Qianxi Vehicle Co., Ltd. | ITI | Class II | 2022-01-10 |
| K211647 | HP358EA Electrically Powered Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | 2022-01-04 |
| K202788 | Sonomed IV, Sonomed V | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | IMI | Class II | 2021-12-23 |
| K213094 | ID-500 iRestore Hair Growth System | Freedom Laser Therapy, Inc. | OAP | Class II | 2021-12-22 |
| K210825 | Revitive Medic Coach (Model Number 5575AQ) | Actegy , Ltd. | NGX | Class II | 2021-12-17 |
| K212832 | TimeWaver Frequency | Timewaver Production GmbH | IPF | Class II | 2021-12-14 |
| K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | Shenzhen Osto Technology Company Limited | NGX | Class II | 2021-12-13 |
| K212762 | geko W-2 | Firstkind Limited | IPF | Class II | 2021-11-29 |
| K212169 | Air compression therapy system FO3002 | Foshan Hongfeng Co., Ltd. | IRP | Class II | 2021-11-23 |
| K213090 | Frontier Series Power Wheelchairs | Magic Mobility | ITI | Class II | 2021-11-19 |
| K213000 | Air Compression Massager (Model LF-FT003) | Wenzhou Lingfeng Electronic Technology Co., Ltd. | IRP | Class II | 2021-11-15 |
| K212595 | Erchonia FX-405 | Erchonia Corporation | NHN | Class II | 2021-11-12 |
| K213383 | WHILL Model C2 | Whill, Inc. | ITI | Class II | 2021-11-09 |
| K212948 | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) | Guangzhou Xinbo Electronic Co., Ltd. | NGX | Class II | 2021-11-01 |
| K211186 | Erchonia XLR8 | Erchonia Corporation | NHN | Class II | 2021-10-22 |
| K200545 | Legend Pro DMA | Pollogen, Ltd. | NGX | Class II | 2021-10-21 |
| K192746 | MyoWorx TM20 | Myoworx, Inc. | IPF | Class II | 2021-10-19 |
| K211745 | RecoveryAir PRO | Theragun, Inc. | IRP | Class II | 2021-10-04 |
| K210002 | STELLA BIO | Egzotech Sp. Z O. O. | IPF | Class II | 2021-10-01 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.