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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K231053
Device Name Unicare (K-UNICARE-USA)
Applicant
Tenscare, Ltd.
9 Blenheim Rd.
Epsom,  GB KT199BE
Applicant Contact Saskia Eldridge-Hinmers
Correspondent
Tenscare, Ltd.
9 Blenheim Rd.
Epsom,  GB KT199BE
Correspondent Contact Saskia Eldridge-Hinmers
Regulation Number882.5890
Classification Product Code
NUH  
Date Received04/13/2023
Decision Date 08/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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