Panels › Physical Medicine › Product code IRP · Class 2
Massager, Powered Inflatable Tube
Regulation 890.5650
13510(k)s in 12 months (158 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in IRP
| Company | 510(k)s | Recalls |
|---|---|---|
| Daesung Maref Co., Ltd. | 8 | 0 |
| NormaTec Industries, LP | 8 | 0 |
| Xiamen Weiyou Intelligent Technology Co., Ltd. | 7 | 0 |
| Mego Afek AC , Ltd. | 6 | 0 |
| Wonjin Mulsan Co., Ltd. | 5 | 0 |
| Chengdu Cryo-Push Medical Technology Co.,Ltd | 4 | 0 |
| Zenith Technical Innovations | 4 | 0 |
| Bio Compression Systems, Inc. | 3 | 0 |
| Coolsystems, Inc. | 2 | 1 |
| Jkh Health Co., Ltd. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2022 | K222669 | Cryopush Cold Compression Device Chengdu Cryo-Push Medical Technology Co.,Ltd, CN | IRP |
| Nov 4, 2022 | K223164 | Aquilo Sports CCT1500 System Aquilo Sports, LLC | IRP |
| Sep 30, 2022 | K222206 | Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) Shenzhen Dongjilian Medical Tech Co., Ltd., CN | IRP |
| Aug 22, 2022 | K201730 | Powered Inflatable Tube Massager - SLIM UP DRAIN Foggiare Technologies, LLC | IRP |
| Jul 14, 2022 | K221666 | Normatec Go NormaTec Industries, LP | IRP |
| Mar 31, 2022 | K213745 | Air Compression Therapy Device, model: ST-502 Shenzhen Future Electronic Co., Ltd., CN | IRP |
| Mar 3, 2022 | K211850 | Air Compression Leg Massager (model: FE-7204B) Xiamen Healthpal Electronic Co.,Ltd, CN | IRP |
| Feb 25, 2022 | K220217 | Normatec 3 NormaTec Industries, LP | IRP |
| Feb 19, 2022 | K212935 | Air Pressure Foot Massager Xiamen Simo Electronic Co., Ltd., CN | IRP |
| Feb 16, 2022 | 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 |
| Jan 18, 2022 | K212713 | Air compression leg massager HY-1117A Xiamen High Top Electronic Technology Co., Ltd., CN | IRP |
| Nov 23, 2021 | K212169 | Air compression therapy system FO3002 Foshan Hongfeng Co., Ltd., CN | IRP |
| Nov 15, 2021 | K213000 | Air Compression Massager (Model LF-FT003) Wenzhou Lingfeng Electronic Technology Co., Ltd., CN | IRP |
| Oct 4, 2021 | K211745 | RecoveryAir PRO Theragun, Inc. | IRP |
| Sep 14, 2021 | K211283 | Compressible Limb and Circulation Therapy System, Model POWER-Q2300 Wonjin Mulsan Co., Ltd., KR | IRP |
| Sep 2, 2021 | K212491 | Air Relax Pro Model AR-4.0 Diode Art Engineering Doing Business AS Air Relax | IRP |
| Sep 1, 2021 | K202395 | SP-1000, SP-2000 Daesung Maref Co., Ltd., KR | IRP |
| Aug 4, 2021 | K210913 | V12 PRO Slk Medical GmbH, DE | IRP |
| Jul 2, 2021 | K203498 | LX9max Daesung Maref Co., Ltd., KR | IRP |
| Jun 22, 2021 | K203019 | LF900 Daesung Maref Co., Ltd., KR | IRP |
| Jun 22, 2021 | K201935 | Air Pressure Therapy System Xiamen Weiyou Intelligent Technology Co., Ltd., CN | IRP |
| Jun 17, 2021 | K210281 | Fist Assist Devices Model FA-1 Fist Assist Devices, LLC | IRP |
| May 25, 2021 | K211460 | Air Relax Plus Model AR-3.0 Diode Art Engineering Doing Business AS Air Relax | IRP |
| May 11, 2021 | K210967 | Air Pressure Therapy System: VU-IPC06 Xiamen Weiyou Intelligent Technology Co., Ltd., CN | IRP |
| Mar 25, 2021 | K201982 | Air compression therapy system FO-3001; Air compression therapy system FO-3008 Foshan Hongfeng Co., Ltd., CN | IRP |
| Mar 8, 2021 | K200660 | Compressible Limb and Circulation Therapy System Wonjin Mulsan Co., Ltd., KR | IRP |
| Mar 5, 2021 | K202693 | NeoWave Pain Relief and Recovery System, Model# T16-2020 Eva Medtec, Inc. | IRP |
| Mar 5, 2021 | K191441 | Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) Maxstar Industrial Co., Ltd., KR | IRP |
| Feb 22, 2021 | K210240 | Air Compression Therapy Device, model HW6007 Konliking Tech & Dev. Limited, CN | IRP |
| Jan 11, 2021 | K193079 | ICE COMPRESSION FIRST, DUO, & MOOVE Systems Mks Paris, FR | IRP |
| Dec 22, 2020 | K203552 | Rapid Reboot Rapid Reboot Recovery Products, LLC | IRP |
| Nov 19, 2020 | K201694 | Air Compression Therapy Device Shenzhen Dongjilian Electronics Co., Ltd., CN | IRP |
| Oct 21, 2020 | K202044 | Powerpress Recovery Unit Hanuri Distribution, Inc. | IRP |
| Sep 15, 2020 | K201645 | Massage Compression Boots Jkh USA, LLC | IRP |
| Aug 5, 2020 | K200351 | PlasmaFlight Manamed, Inc. | IRP |
| Jun 22, 2020 | K192466 | Air Compression Therapy System Shenzhen Lifotronic Technology Co., Ltd., CN | IRP |
| Jun 8, 2020 | K193354 | Air Compression Therapy Device Shenzhen Dongjilian Electronics Co., Ltd., CN | IRP |
| Apr 23, 2020 | K192358 | Pressure Therapy System PT1003 Xiamen Senyang Co., Ltd., CN | IRP |
| Feb 28, 2020 | K193550 | Therm-X Zenith Technical Innovations | IRP |
| Dec 19, 2019 | K192607 | LiteWalk Viasonix , Ltd., IL | IRP |
| Oct 29, 2019 | K192114 | Game Ready GRPro 2.1 System Cool Systems, Inc. (Dba Game Ready) | IRP |
| Oct 29, 2019 | K191862 | Compression Therapy Device Model LGT-2200SP Guangzhou Longest Science & Technology Co., Ltd., CN | IRP |
| Sep 19, 2019 | K192252 | ProPerformance Recovery System Menlo Brands, LLC | IRP |
| May 30, 2019 | K173158 | Air Relax Maxstar Industrial Co., Ltd., KR | IRP |
| May 15, 2019 | K190493 | Recovery Pump, 737R (RPX) Mego Afek AC , Ltd., IL | IRP |
| May 10, 2019 | K190854 | Therm-X Zenith Technical Innovations | IRP |
| Mar 25, 2019 | K190015 | Ballancer Gold, 1212 Mego Afek AC , Ltd., IL | IRP |
| Mar 1, 2019 | K183702 | Polar Care Wave Breg, Inc. | IRP |
| Feb 19, 2019 | K181409 | Pressure Therapy System PT1003 Xiamen Senyang Co., Ltd., CN | IRP |
| Dec 27, 2018 | K183169 | Pulse 2.0, Pulse Pro 2.0 NormaTec Industries, LP | IRP |
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