Primus

FDA UDI

Class II (US FDA UDI)

by Bte Technologies

Identity

Trade Name: Primus FDA UDI
Generic Name: Biomechanical function analysis system, force-testing, stationary FDA UDI
Device Name: A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions. FDA UDI
Model / Reference: Primus+ FDA UDI
Description: A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions. FDA UDI

Identifiers

Primary DI / UDI-DI: 10850390007236 FDA UDI
510(k) Number: K933611 FDA UDI
FDA Product Code: ISD FDA UDI
GMDN Term: Biomechanical function analysis system, force-testing, stationary FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5360 FDA UDI
Commercial Distribution: Not 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Primus by Bte Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K933611 also covers:

PrimusRS — BTE TECHNOLOGIES

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 II	Pending data

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Manufacturer

Manufacturer: Bte Technologies

Sources (1)

FDA UDI 165f40bb-b283-4b26-b0a2-7c77d546eb5c 37 fields · synced Jun 8, 2026