E-LINK R500 ROM Kit (Range of Motion)

FDA UDI

Class I (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: E-LINK R500 ROM Kit (Range of Motion) FDA UDI
Generic Name: Electronic goniometer/kinesiology sensor FDA UDI
Device Name: Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting. The Biometrics Range of Motion Kit (R500) provides precise electronic tools for: upper and lower extremity range of motion measurements FDA UDI
Model / Reference: R500 FDA UDI
Description: Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting. The Biometrics Range of Motion Kit (R500) provides precise electronic tools for: upper and lower extremity range of motion measurements FDA UDI

Identifiers

Primary DI / UDI-DI: 05060481690072 FDA UDI
FDA Product Code: KQX FDA UDI
ISD FDA UDI
GMDN Term: Electronic goniometer/kinesiology sensor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.1500 FDA UDI
890.5360 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

FDA UDI

Category: Electronic goniometer/kinesiology sensor

E-LINK R500 ROM Kit (Range of Motion) by Biometrics Limited — 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: Biometrics Limited

Sources (1)

FDA UDI c806e7a7-4ebb-44f1-87b5-7e3d5abcfbc4 33 fields · synced Jun 1, 2026