Hyperice PRO26-Tl
Hyperice PRO26-Tl is a sequential venous compression system (FDA Class II) made by Normatec Industries, LP, cleared under FDA 510(k) K261887 on 6 Oct 2026 and listed in FDA GUDID since 19 Oct 2026 (UDI-DI 00810050289276), active as of 2 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00810050289276 | Date19 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK261887 | Date6 Oct 2026 | StatusActive |
Official records
- AccessGUDID record 00810050289276
- FDA 510(k) database K261887
Across registries
- FDA 510(k) K261887 decided 6 Oct 2026 Active
- FDA GUDID UDI-DI 00810050289276 listed 19 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K261887
- Listed FDA GUDID 00810050289276
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hyperice
- Generic name
- Sequential venous compression system
- Model / reference
- PRO26-TL
- Primary DI / UDI-DI
- 00810050289276
- 510(k) Number
- FDA product code
- IRT, IRP
- GMDN term
- Sequential venous compression system
- Device class
- Class II
- Regulation number
- 890.5740, 890.5650
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IRT (Pad, Heating, Powered).
- THERATHERM by Electro Therapeutic Devices, Inc.
- Heated Eye Pad by DIGITAL HEAT CORPORATION
- MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK by Clairol, Inc.
- SOLEX THERAPEUTIC PAD by Intl. Diathermics Research, Inc.
- FEMININE HEAT WRAP by CONAIR LLC.
- FORMOSTAR by Lmv, Liske & Methling, GmbH
- HYDRO-THERO PAD by Maddak, Inc.
- bite away neo by mibeTec GmbH
- HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 by Sunbeam Health Division
- THERMAL CONDITIONING SYSTEM by Acurex Aerotherm