Skip to content

rebless

by H Robotics Inc.

Ref 2018Model RHSW

rebless (2018) is an ankle continuous passive motion exerciser (EU MDR Class I; FDA Class I; FDA product code BXB, Exerciser, Powered) made by H Robotics Inc., registered in EUDAMED on 6 Jul 2023 (Basic UDI-DI 880010160RHSWAN) and listed in FDA GUDID since 16 Mar 2021 (UDI-DI 08800101600015), active as of 22 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880010160RHSWAN Basic UDI-DI 08800101600015UDI-DIDate6 Jul 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08800101600015 UDI-DI Date16 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880010160RHSWAN registered 6 Jul 2023 Active
  • FDA GUDID UDI-DI 08800101600015 listed 16 Mar 2021 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 08800101600015
  2. Registered EUDAMED 880010160RHSWAN

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  • Withdrawn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

Generic name
Ankle continuous passive motion exerciser
Model / reference
RHSW, 2018
Primary DI / UDI-DI
08800101600015
Basic UDI-DI
880010160RHSWAN
Direct marketing DI
08800101600015
FDA product code
BXB
EMDN code
Z12069099 Various physiotherapy and rehabilitation instruments - other
GMDN term
Ankle continuous passive motion exerciser
Device class
Class I
Regulation number
890.5380
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
KR-MF-000011627
Authorised representative
KTR Europe GmbH DE-AR-000005685

Similar devices in this category

Other devices filed under VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER.

Other devices from H Robotics Inc.

See all devices from H Robotics Inc. →

Properties

  • Single use
  • Premarket exempt
Other properties (23, all answered No)