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FDA 510(k) Application Details - K192733
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K192733
Device Name
Stimulator, Muscle, Powered
Applicant
Umeheal Ltd.
Floor 5, Bld F4, 1001 Zhongshanyuan Rd
TCL E City, Nanshan District
Shenzhen 518055 CN
Other 510(k) Applications for this Company
Contact
Rui Lin
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
IPF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2019
Decision Date
12/23/2019
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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