IRP · Massager, Powered Inflatable Tube
Physical Medicine · 21 CFR 890.5650 · Class 2
Overview
| Product Code | IRP |
|---|---|
| Device Name | Massager, Powered Inflatable Tube |
| Regulation | 21 CFR 890.5650 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 149)
Showing 20 most recent of 149 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252386 | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | Apr 3, 2026 | SESE |
| K253076 | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | Apr 2, 2026 | SESE |
| K251622 | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | Jan 28, 2026 | SESE |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) | Shenzhen Future Electronic Co., Ltd. | Nov 13, 2025 | SESE |
| K251531 | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | Oct 30, 2025 | SESE |
| K253150 | Cryon-X Cold Compression | Jkh Health Co., Ltd. | Oct 24, 2025 | SESE |
| K251905 | Normatec Elite Hip | NormaTec Industries, LP | Sep 18, 2025 | SESE |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | Shenzhen Yicai Health Technology Co., Ltd. | Sep 17, 2025 | SESE |
| K250244 | Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. | Jul 25, 2025 | SESE |
| K242615 | Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) | Xiamen Taotao Technology Co., Ltd. | Jul 23, 2025 | SESE |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. | May 5, 2025 | SESE |
| K250046 | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Shenzhen Urion Technology Co., Ltd. | Apr 25, 2025 | SESE |
| K242140 | Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. | Mar 17, 2025 | SESE |
| K243206 | 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. | Feb 19, 2025 | SESE |
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | Avanos Medical, Inc. | Jan 31, 2025 | SESE |
| K243791 | Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | Jan 13, 2025 | SESE |
| K243177 | SACS PRO | Elastimed , Ltd. | Dec 23, 2024 | SESE |
| K232965 | Leg Massager (Models:RP-ALM070H, RP-ALM071H) | Shenzhen Ruiyi Business Technology Co., Ltd. | Nov 20, 2024 | SESE |
| K243320 | Air Pressure Therapy System (VU-IPC04B) | Xiamen Weiyou Intelligent Technology Co., Ltd. | Nov 18, 2024 | SESE |
| K242940 | Xrecovery (XR-001) | Shenzhen Xinrun Electric Appliances Co, Ltd. | Nov 14, 2024 | SESE |
Top Applicants
- Daesung Maref Co., Ltd. — 8 clearances
- NormaTec Industries, LP — 7 clearances
- Mego Afek AC , Ltd. — 6 clearances
- Wonjin Mulsan Co., Ltd. — 5 clearances
- Xiamen Weiyou Intelligent Technology Co., Ltd. — 5 clearances
