IRP — Massager, Powered Inflatable Tube Class II
FDA product code IRP covers "Massager, Powered Inflatable Tube", a Class II medical device regulated under 21 CFR 890.5650. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IRP
- Device Class
- Class II
- Regulation Number
- 890.5650
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253919 | xiamen weiyou intelligent technology co | Cryo And Thermo Therapy System | June 10, 2026 |
| K252396 | avanutri equipamentos de saúde | Cryo Sport 2.0 (AVA 501) | May 29, 2026 |
| K254200 | wenzhou lingfeng electronic technology co | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT0 | May 5, 2026 |
| K253064 | xiamen weiyou intelligent technology co | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); | April 30, 2026 |
| K252386 | chengdu cryo-push medical technology co | Hot and Cold Compression System (A02-C-032) | April 3, 2026 |
| K253076 | chengdu cryo-push medical technology co | Cryopush Cold Compression Device (A02-P-001) | April 2, 2026 |
| K251622 | ningbo zhenhai yihao electronic technology co | Hand Massager (SM004D) | January 28, 2026 |
| K251662 | shenzhen future electronic co | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505) | November 13, 2025 |
| K251531 | merchsource | AIR COMPRESSION BOOTS 1018195,1018196 | October 30, 2025 |
| K253150 | jkh health co | Cryon-X Cold Compression | October 24, 2025 |
| K251905 | normatec industries | Normatec Elite Hip | September 18, 2025 |
| K251623 | shenzhen yicai health technology co | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | September 17, 2025 |
| K250244 | guangzhou longest medical technology co | Compression Therapy Device (LGT-2210DS) | July 25, 2025 |
| K242615 | xiamen taotao technology co | Intermittent pressure compression system (Compression Pump PT1005A; Leg Compress | July 23, 2025 |
| K242754 | zamar medical | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | May 5, 2025 |
| K250046 | shenzhen urion technology co | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM6 | April 25, 2025 |
| K242140 | jiale health technology shenzhen co | Air Compression Leg Massager (K-705) | March 17, 2025 |
| K243206 | sichuan qianli-beoka medical technology | Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, AC | February 19, 2025 |
| K243572 | avanos medical | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready | January 31, 2025 |
| K243791 | xiamen weiyou intelligent technology co | Air Pressure Therapy System | January 13, 2025 |