FDA 510(k) Application Details - K210979

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K210979
Device Name Stimulator, Muscle, Powered
Applicant Rehabtronics Inc.
#4352, 10230 Jasper Avenue
Edmonton T5J 4P6 CA
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Contact Mike Pearson
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 04/01/2021
Decision Date 05/13/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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