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rebless RHSW

by H Robotics Inc. 9 variants

rebless RHSW is an ankle continuous passive motion exerciser (FDA Class I; FDA product code BXB, Exerciser, Powered) made by H Robotics Inc., registered in EUDAMED and listed in FDA GUDID since 18 Mar 2021 (UDI-DI 08800101600077), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800101600077 UDI-DI Date18 Mar 2021ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 08800101600077 listed 18 Mar 2021 Listed

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
rebless
Generic name
Ankle continuous passive motion exerciser
Model / reference
RHSW
Primary DI / UDI-DI
08800101600077
FDA product code
BXB
GMDN term
Ankle continuous passive motion exerciser
Device class
Class I
Regulation number
890.5380
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code BXB (Exerciser, Powered).

Other devices from H Robotics Inc.

See all devices from H Robotics Inc. →

Properties

  • Premarket exempt
Other properties (14, all answered No)