IRP · Class II · 21 CFR 890.5650

FDA Product Code IRP: Massager, Powered Inflatable Tube

Leading manufacturers include Daesung Maref Co., Ltd., NormaTec Industries, LP and Xiamen Weiyou Intelligent Technology Co., Ltd..

156
Total
156
Cleared
154d
Avg days
1978
Since
156 devices
97–120 of 156
Cleared Feb 19, 2019
Pressure Therapy System PT1003
K181409
Xiamen Senyang Co., Ltd.
Physical Medicine · 265d
Cleared Dec 27, 2018
Pulse 2.0, Pulse Pro 2.0
K183169
NormaTec Industries, LP
Physical Medicine · 41d
Cleared Dec 14, 2018
Rapid Reboot Compression Therapy System
K182668
Rapid Reboot Recovery Products, LLC
Physical Medicine · 80d
Cleared Aug 03, 2018
Therm-X Pro, Therm-X AT, Therm-X Pro Athlete
K181149
Zenith Technical Innovations
Physical Medicine · 94d
Cleared Sep 29, 2017
Med4 Elite
K171685
Cool Systems, Inc. (Dba Game Ready)
Physical Medicine · 114d
Cleared Feb 23, 2017
Pressure Therapy System
K161907
Xiamen Senyang Co., Ltd.
Physical Medicine · 226d
Cleared Jan 27, 2017
RP Lite 760R
K163280
Mego Afek AC , Ltd.
Physical Medicine · 67d
Cleared Jan 11, 2017
Lympha-Flow(LF1200)
K160178
Daesung Maref Co., Ltd.
Physical Medicine · 350d
Cleared Apr 13, 2016
NormaTec Pulse and NormaTec Pulse Pro
K160608
NormaTec Industries, LP
Physical Medicine · 41d
Cleared May 26, 2015
Ballancer 505 System, Model 1201-AC
K150269
Mego Afek AC , Ltd.
Physical Medicine · 111d
Cleared Apr 20, 2015
Air Compressible Limb Therapy System
K150033
Daesung Maref Co., Ltd.
Physical Medicine · 101d
Cleared Dec 23, 2014
Nice1
K143197
Nice Recovery Systems, LLC
Physical Medicine · 47d
Cleared Jun 16, 2014
RECOVERY PUMP 737R
K140519
Mego Afek AC , Ltd.
Physical Medicine · 108d
Cleared Mar 11, 2014
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
K133483
Portable Therapeutix
Physical Medicine · 118d
Cleared Feb 18, 2014
COMPRESSIBLE LIMB SLEEVE SYSTEM
K130385
Maxstar Industrial Co., Ltd.
Physical Medicine · 368d
Cleared Apr 09, 2013
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
K122112
Bio Compression Systems, Inc.
Physical Medicine · 266d
Cleared Apr 03, 2013
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
K123829
Portable Therapeutix, LLC
Physical Medicine · 112d
Cleared Nov 21, 2012
POWERPLAY MUSCLE MASSAGER
K122154
Fig, LLC
Physical Medicine · 124d
Cleared May 14, 2012
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K120166
Won Industrial Co.
Physical Medicine · 116d
Cleared Feb 27, 2012
COMPRESSIBLE LIMB THERAPY SYSTEM
K113275
Wonjin Mulsan Co., Ltd.
Physical Medicine · 115d
Cleared Jan 17, 2012
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K112441
Daesung Maref Co., Ltd.
Physical Medicine · 146d
Cleared Jan 04, 2012
NORMATEC MVP
K112890
NormaTec Industries, LP
Physical Medicine · 96d
Cleared Dec 07, 2011
DSJ MASSAGER
K112479
Mego Afek AC , Ltd.
Physical Medicine · 100d
Cleared Mar 04, 2011
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
K102320
Daesung Maref Co., Ltd.
Physical Medicine · 199d