Data / Medical devices / United States / Bte Technologies

Bte Technologies: FDA-registered device maker in Hanover, MD, United States, 2 510(k) clearances

Name: Bte Technologies FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bte Technologies is registered with the FDA (registration 1119903) in Hanover, MD, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 20, 1994. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1119903
Address: 7455-L New Ridge RD., Hanover, MD, United States, 21076
Owner or operator: BTE TECHNOLOGIES (1119903)
Roles: Manufacturer, Repackager or relabeler
First device listed: August 31, 1992
Registered through: 2026
Brand names listed: Alfa, Capri, EVJ, Eccentron, EvalTech, Evaluator, MCU Multi-Cervical Unit, PrimusRS and more

Devices it lists

Device	Product code	Class	Role	Source
Exerciser, Measuring	ISD	2	Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Repackager or relabeler	accessdata.fda.gov
Exerciser, Powered	BXB	1	Manufacturer	accessdata.fda.gov
Platform, Force-Measuring	KHX	1	Repackager or relabeler	accessdata.fda.gov
System, Isokinetic Testing And Evaluation	IKK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 20, 1994	K933611	THE BTE WS30	ISD	Substantially Equivalent	Baltimore Therapeutic Equipment Co.	accessdata.fda.gov
January 21, 1980	K800007	WORK SIMULATOR	BXB	Substantially Equivalent	Baltimore Therapeutic Equipment Co.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 9, 2015	71443	Class II	Terminated	Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus t	On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use scenarios when the bar is rotated and twisted around the snap hook. The snap hook could open, resulting in possible injury to the user due to a fall.	accessdata.fda.gov

Compare with other makers

Updated July 6, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.