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
Stable submission activity - 27 submissions in the last 2 years
Consistent review times:
164d avg (recent)
FDA 510(k) Cleared Massager, Powered Inflatable Tube Devices (Product Code IRP)
156 devices
Cleared
Aug 12, 2026
ManaCold Compression System
Manamed, LLC
Physical Medicine
142d
Cleared
Jul 27, 2026
Air Compression Massager (HY-1165)
Xiamen High Top Electronic Technology Co., Ltd.
Physical Medicine
160d
Cleared
Jul 24, 2026
Air Compression Massager (EP30B001 I)
Wavepulse (Xiamen) Healthcare Technology Co., Ltd.
Physical Medicine
123d
Cleared
Jun 10, 2026
Cryo And Thermo Therapy System
Xiamen Weiyou Intelligent Technology Co., Ltd.
Physical Medicine
184d
Cleared
May 29, 2026
Cryo Sport 2.0 (AVA 501)
Avanutri Equipamentos DE Saúde
Physical Medicine
302d
Cleared
May 05, 2026
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)
Wenzhou Lingfeng Electronic Technology Co., Ltd.
Physical Medicine
127d
Cleared
Apr 30, 2026
Air Pressure Therapy System (VU-IPC8M)
Xiamen Weiyou Intelligent Technology Co., Ltd.
Physical Medicine
220d
Cleared
Apr 03, 2026
Hot and Cold Compression System (A02-C-032)
Chengdu Cryo-Push Medical Technology Co.,Ltd
Physical Medicine
246d
Cleared
Apr 02, 2026
Cryopush Cold Compression Device (A02-P-001)
Chengdu Cryo-Push Medical Technology Co.,Ltd
Physical Medicine
191d
Cleared
Jan 28, 2026
Hand Massager (SM004D)
Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
Physical Medicine
245d
Cleared
Nov 13, 2025
Air Compression Therapy Device (ST-504)
Shenzhen Future Electronic Co., Ltd.
Physical Medicine
167d
Cleared
Oct 30, 2025
AIR COMPRESSION BOOTS 1018195,1018196
Merchsource, LLC
Physical Medicine
164d
Cleared
Oct 24, 2025
Cryon-X Cold Compression
Jkh Health Co., Ltd.
Physical Medicine
29d
Cleared
Sep 18, 2025
Normatec Elite Hip
NormaTec Industries, LP
Physical Medicine
90d
Cleared
Sep 17, 2025
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
Shenzhen Yicai Health Technology Co., Ltd.
Physical Medicine
112d
Cleared
Jul 25, 2025
Compression Therapy Device (LGT-2210DS)
Guangzhou Longest Medical Technology Co., Ltd.
Physical Medicine
179d
Cleared
Jul 23, 2025
Intermittent pressure compression system (Compression Pump PT1005A
Xiamen Taotao Technology Co., Ltd.
Physical Medicine
323d
Cleared
May 05, 2025
ZT Clinic (MG675A)
Zamar Medical D.O.O.
Physical Medicine
235d
Cleared
Apr 25, 2025
Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
Shenzhen Urion Technology Co., Ltd.
Physical Medicine
105d
Cleared
Mar 17, 2025
Air Compression Leg Massager (K-705)
Jiale Health Technology Shenzhen Co., Ltd.
Physical Medicine
238d
Cleared
Feb 19, 2025
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
Sichuan Qianli-Beoka Medical Technology, Inc.
Physical Medicine
141d
Cleared
Jan 31, 2025
Game Ready system (550500-04)
Avanos Medical, Inc.
Physical Medicine
74d
Cleared
Jan 13, 2025
Air Pressure Therapy System
Xiamen Weiyou Intelligent Technology Co., Ltd.
Physical Medicine
34d
Cleared
Dec 23, 2024
SACS PRO
Elastimed , Ltd.
Physical Medicine
84d
About Product Code IRP - Regulatory Context
510(k) Submission Activity
156 total 510(k) submissions under product code IRP since 1978, with 156 receiving FDA clearance (average review time: 154 days).
Submission volume has remained relatively stable over the observed period, with 27 submissions in the last 24 months.
FDA 510(k) Review Time - IRP Product Code
FDA review times for IRP submissions have been consistent, averaging 164 days recently vs 152 days historically.
IRP devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →