IRP · Class II · 21 CFR 890.5650

FDA Product Code IRP: Massager, Powered Inflatable Tube

Leading manufacturers include Xiamen Weiyou Intelligent Technology Co., Ltd., NormaTec Industries, LP and Zenith Technical Innovations.

153
Total
153
Cleared
154d
Avg days
1978
Since
153 devices
49–72 of 153
Cleared Jul 14, 2022
Normatec Go
K221666
NormaTec Industries, LP
Physical Medicine · 36d
Cleared Mar 31, 2022
Air Compression Therapy Device, model: ST-502
K213745
Shenzhen Future Electronic Co., Ltd.
Physical Medicine · 122d
Cleared Mar 03, 2022
Air Compression Leg Massager (model: FE-7204B)
K211850
Xiamen Healthpal Electronic Co.,Ltd
Physical Medicine · 261d
Cleared Feb 25, 2022
Normatec 3
K220217
NormaTec Industries, LP
Physical Medicine · 30d
Cleared Feb 19, 2022
Air Pressure Foot Massager
K212935
Xiamen Simo Electronic Co., Ltd.
Physical Medicine · 157d
Cleared Feb 16, 2022
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
K213533
Bio Compression Systems, Inc.
Physical Medicine · 103d
Cleared Jan 18, 2022
Air compression leg massager HY-1117A
K212713
Xiamen High Top Electronic Technology Co., Ltd.
Physical Medicine · 145d
Cleared Nov 23, 2021
Air compression therapy system FO3002
K212169
Foshan Hongfeng Co., Ltd.
Physical Medicine · 134d
Cleared Nov 15, 2021
Air Compression Massager (Model LF-FT003)
K213000
Wenzhou Lingfeng Electronic Technology Co., Ltd.
Physical Medicine · 56d
Cleared Oct 04, 2021
RecoveryAir PRO
K211745
Theragun, Inc.
Physical Medicine · 119d
Cleared Sep 14, 2021
Compressible Limb and Circulation Therapy System, Model POWER-Q2300
K211283
Wonjin Mulsan Co., Ltd.
Physical Medicine · 140d
Cleared Sep 02, 2021
Air Relax Pro Model AR-4.0
K212491
Diode Art Engineering Doing Business AS Air Relax
Physical Medicine · 24d
Cleared Sep 01, 2021
SP-1000, SP-2000
K202395
Daesung Maref Co., Ltd.
Physical Medicine · 376d
Cleared Aug 04, 2021
V12 PRO
K210913
Slk Medical GmbH
Physical Medicine · 128d
Cleared Jul 02, 2021
LX9max
K203498
Daesung Maref Co., Ltd.
Physical Medicine · 217d
Cleared Jun 22, 2021
Air Pressure Therapy System
K201935
Xiamen Weiyou Intelligent Technology Co., Ltd.
Physical Medicine · 344d
Cleared Jun 22, 2021
LF900
K203019
Daesung Maref Co., Ltd.
Physical Medicine · 264d
Cleared Jun 17, 2021
Fist Assist Devices Model FA-1
K210281
Fist Assist Devices, LLC
Physical Medicine · 136d
Cleared May 25, 2021
Air Relax Plus Model AR-3.0
K211460
Diode Art Engineering Doing Business AS Air Relax
Physical Medicine · 14d
Cleared May 11, 2021
Air Pressure Therapy System: VU-IPC06
K210967
Xiamen Weiyou Intelligent Technology Co., Ltd.
Physical Medicine · 41d
Cleared Mar 25, 2021
Air compression therapy system FO-3001
K201982
Foshan Hongfeng Co., Ltd.
Physical Medicine · 251d
Cleared Mar 08, 2021
Compressible Limb and Circulation Therapy System
K200660
Wonjin Mulsan Co., Ltd.
Physical Medicine · 361d
Cleared Mar 05, 2021
Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
K191441
Maxstar Industrial Co., Ltd.
Physical Medicine · 645d
Cleared Mar 05, 2021
NeoWave Pain Relief and Recovery System, Model# T16-2020
K202693
Eva Medtec, Inc.
Physical Medicine · 171d