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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 K212918
Device Name Heat StimPlus
Applicant
Famidoc Technology Co., Ltd.
#212 Yilong Rd., Hexi Industrial Zone, Jinxia,
Changan Town
Dongguan,  CN 523853
Applicant Contact Amos Zou
Correspondent
Famidoc Technology Co., Ltd.
#212 Yilong Rd., Hexi Industrial Zone, Jinxia,
Changan Town
Dongguan,  CN 523853
Correspondent Contact Amos Zou
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/14/2021
Decision Date 12/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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