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rebless

FDA UDIEUDAMED

Class I (US FDA UDI)

by H Robotics Inc.

Identity

Trade Name
rebless FDA UDI
Generic Name
Ankle continuous passive motion exerciser FDA UDI
Device Name
Adapter cable FDA UDI
Model / Reference
RHSW FDA UDI
Description
Adapter cable FDA UDI

Identifiers

Primary DI / UDI-DI
08800101600077 FDA UDI
FDA Product Code
BXB FDA UDI
GMDN Term
Ankle continuous passive motion exerciser FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Continuous passive motion joint exerciserHand/wrist continuous passive motion exerciserAnkle continuous passive motion exerciser

rebless by H Robotics Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Ankle continuous passive motion exerciser.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
H Robotics Inc.

Sources (2)

  • FDA UDI 4e8ca313-909f-4e6e-8235-e4879b144f49 33 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026