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Hyperice PRO26-St

by Normatec Industries, LP

Hyperice PRO26-St 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 00810050289269), active as of 2 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 2 Nov 2026

Documents

510(k) K261887

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810050289269 UDI-DI Date19 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK261887 Date6 Oct 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261887 decided 6 Oct 2026 Active
  • FDA GUDID UDI-DI 00810050289269 listed 19 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261887
  2. Listed FDA GUDID 00810050289269

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hyperice
Generic name
Sequential venous compression system
Model / reference
PRO26-ST
Primary DI / UDI-DI
00810050289269
510(k) Number
FDA product code
IRP, IRT
GMDN term
Sequential venous compression system
Device class
Class II
Regulation number
890.5650, 890.5740
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261887)

and 1 more cleared under K261887

Similar devices

Other devices filed under FDA product code IRP (Massager, Powered Inflatable Tube).

Other devices from Normatec Industries, LP

  • Hyperice PRO26-Sh

    Class II

  • Hyperice PRO26-Tl

    Class II

  • Hyperice PRO26-Ph

    Class II

  • Hyperice PRO26-Ps

    Class II

See all devices from Normatec Industries, LP →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)