Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5650](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5650) → IRP — Massager, Powered Inflatable Tube # IRP · Massager, Powered Inflatable Tube _Physical Medicine · 21 CFR 890.5650 · Class 2_ **Canonical URL:** https://fda-staging.innolitics.com/productcode/IRP ## Overview - **Product Code:** IRP - **Device Name:** Massager, Powered Inflatable Tube - **Regulation:** [21 CFR 890.5650](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5650) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) - **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 156) Showing 20 most recent of 156 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260944](/device/K260944.md) | ManaCold Compression System | Manamed, LLC | Aug 12, 2026 | SESE | | [K260529](/device/K260529.md) | Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. | Jul 27, 2026 | SESE | | [K260948](/device/K260948.md) | Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | Jul 24, 2026 | SESE | | [K253919](/device/K253919.md) | Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. | Jun 10, 2026 | SESE | | [K252396](/device/K252396.md) | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | May 29, 2026 | SESE | | [K254200](/device/K254200.md) | 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. | May 5, 2026 | SESE | | [K253064](/device/K253064.md) | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co., Ltd. | Apr 30, 2026 | SESE | | [K252386](/device/K252386.md) | Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd | Apr 3, 2026 | SESE | | [K253076](/device/K253076.md) | Cryopush Cold Compression Device (A02-P-001) | Chengdu Cryo-Push Medical Technology Co.,Ltd | Apr 2, 2026 | SESE | | [K251622](/device/K251622.md) | Hand Massager (SM004D) | Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. | Jan 28, 2026 | SESE | | [K251662](/device/K251662.md) | 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](/device/K251531.md) | AIR COMPRESSION BOOTS 1018195,1018196 | Merchsource, LLC | Oct 30, 2025 | SESE | | [K253150](/device/K253150.md) | Cryon-X Cold Compression | Jkh Health Co., Ltd. | Oct 24, 2025 | SESE | | [K251905](/device/K251905.md) | Normatec Elite Hip | NormaTec Industries, LP | Sep 18, 2025 | SESE | | [K251623](/device/K251623.md) | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | Shenzhen Yicai Health Technology Co., Ltd. | Sep 17, 2025 | SESE | | [K250244](/device/K250244.md) | Compression Therapy Device (LGT-2210DS) | Guangzhou Longest Medical Technology Co., Ltd. | Jul 25, 2025 | SESE | | [K242615](/device/K242615.md) | 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](/device/K242754.md) | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical D.O.O. | May 5, 2025 | SESE | | [K250046](/device/K250046.md) | Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Shenzhen Urion Technology Co., Ltd. | Apr 25, 2025 | SESE | | [K242140](/device/K242140.md) | Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. | Mar 17, 2025 | SESE | ## Top Applicants - Daesung Maref Co., Ltd. — 8 clearances - NormaTec Industries, LP — 7 clearances - Xiamen Weiyou Intelligent Technology Co., Ltd. — 7 clearances - Mego Afek AC , Ltd. — 6 clearances - Wonjin Mulsan Co., Ltd. — 5 clearances --- **Source:** [https://fda-staging.innolitics.com/productcode/IRP](https://fda-staging.innolitics.com/productcode/IRP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com