BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set

Stimulator, Muscle, Powered, For Muscle Conditioning

Bemer INT. AG

The following data is part of a premarket notification filed by Bemer Int. Ag with the FDA for Bemer Therapy Systems, Bemer Classic Set, Bemer Pro-set.

Pre-market Notification Details

Device IDK210174
510k NumberK210174
Device Name:BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Bemer INT. AG Austrasse 15 Triesen,  LI 9495
ContactSandra Schwarzenberger
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-01-22
Decision Date2021-02-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07640161461086 K210174 000
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07640161460218 K210174 000
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07640161460218 K210174 000
07640161461086 K210174 000
07640161460218 K210174 000
07640161461086 K210174 000
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07640161461086 K210174 000
07640161460218 K210174 000
07640161461086 K210174 000
07640161460218 K210174 000
07640161461086 K210174 000
07640161460218 K210174 000
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07640161460218 K210174 000
07640161461086 K210174 000
07640161460218 K210174 000
07640161461086 K210174 000
07640161460218 K210174 000

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