Gait Trainer 3

FDA UDI

Class I (US FDA UDI)

by Biodex Medical Systems

Identity

Trade Name: Gait Trainer 3 FDA UDI
Generic Name: Standard treadmill, powered FDA UDI
Device Name: Gait Trainer 3, 115 VAC, 12.1" LCD with Extended Handrails FDA UDI
Model / Reference: 950-402 FDA UDI
Description: Gait Trainer 3, 115 VAC, 12.1" LCD with Extended Handrails FDA UDI

Identifiers

Catalog Number: 950-402 FDA UDI
Primary DI / UDI-DI: 00718175005422 FDA UDI
FDA Product Code: IOL FDA UDI
GMDN Term: Standard treadmill, powered 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Standard treadmill, powered

Gait Trainer 3 by Biodex Medical Systems — 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: Biodex Medical Systems

Sources (1)

FDA UDI 6c825ac2-ccbf-41d1-a28c-537bd6faf1ff 34 fields · synced Jun 8, 2026