Facility

BTE TECHNOLOGIES

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1119903
Establishment type	Manufacture Medical Device
Location	7455-L NEW RIDGE RD. HANOVER, MD, US 21076
Registration status	Active · expires 2026
Parent company	BTE TECHNOLOGIES (owner-operator 1119903)
Brand names	PrimusRS

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Exerciser, Measuring
Product code ISD (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5360

Recalls & enforcement

Class IITerminated2015-04-09
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, resulti…

FDA inspections (3)

NAI2026-06-29
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2020-01-31
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-02-26
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by BTE TECHNOLOGIES

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BTE TECHNOLOGIES (FEI 1119903) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1119903-bte-technologies/

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