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FDA 510(k) Application Details - K220538
Device Classification Name
Massager, Therapeutic, Electric
More FDA Info for this Device
510(K) Number
K220538
Device Name
Massager, Therapeutic, Electric
Applicant
EMS Electro Medical Systems SA
Ch. de la Vuarpilliere 31
Nyon 1260 CH
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Contact
TimothΘe Deblock
Other 510(k) Applications for this Contact
Regulation Number
890.5660
More FDA Info for this Regulation Number
Classification Product Code
ISA
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More FDA Info for this Product Code
Date Received
02/25/2022
Decision Date
07/11/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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