Facility

BTT HEALTH GMBH

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3013515165
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	Beurer Str. 25a Greifenberg Bavaria, DE 86926
Registration status	Active · expires 2026
Parent company	BTT Health GmbH (owner-operator 10054048)
Brand names	Marodyne LiV System

Activity by year

Recalls (1)

Devices registered here (1)

Exerciser, Powered
Product code BXB (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.5380

Recalls & enforcement

Class IIOngoing2024-08-01
Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).

All facilities operated by BTT Health GmbH

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. “BTT HEALTH GMBH (FEI 3013515165) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013515165-btt-health-gmbh/

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