FDA 510(k) Application Details - K210269

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K210269
Device Name Stimulator, Muscle, Powered
Applicant Smartmissimo Technologies Pte Ltd
#28-01, SGX Centre II, 4 Shenton Way
Singapore 068807 SG
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Contact Alexey Pisarev
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 02/01/2021
Decision Date 02/23/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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