Balance Harness

FDA UDI

Class I (US FDA UDI)

by MASS Rehab Inc.

Identity

Trade Name: Balance Harness FDA UDI
Generic Name: Gait rehabilitation system harness FDA UDI
Device Name: Balance harness for balance training activities FDA UDI
Model / Reference: Standard FDA UDI
Description: Balance harness for balance training activities FDA UDI

Identifiers

Primary DI / UDI-DI: G505MRBHS0 FDA UDI
FDA Product Code: IOD FDA UDI
GMDN Term: Gait rehabilitation system harness FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Gait rehabilitation system harness

Balance Harness by MASS Rehab Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: MASS Rehab Inc.

Sources (1)

FDA UDI 83c50134-a63a-4e5c-8597-3225e1fd6fc0 33 fields · synced Jun 8, 2026