FDA-Device2021-02-17Class II
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)
BEMER INT. AG
Hazard
There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker.
Sold states
US
Affected count
197,724 units
Manufactured in
Austrasse 15, N/A, Triesen, N/A, Liechtenstein
Products
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1105-2021Don't want to check this manually?
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