FDA 510(k) Application Details - K220601

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K220601
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant Zimmer MedizinSysteme GmbH
Junkersstrasse 9
Neu-Ulm 89231 DE
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Contact Julia Kredler
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 03/02/2022
Decision Date 04/01/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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