FDA 510(k)

Heat StimPlus

Numéro K : K212918 · 2021-12-13

Date de décision2021-12-13

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Heat StimPlus is the device name listed in this FDA 510(k) record. The listed applicant is Famidoc Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212918. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Heat StimPlus?

Heat StimPlus is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Famidoc Technology Co., Ltd.. The 510(k) number is K212918.

When did Heat StimPlus receive FDA 510(k) clearance?

Heat StimPlus received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212918.

Who is the listed applicant for Heat StimPlus?

The FDA 510(k) record lists Famidoc Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heat StimPlus?

The FDA product code for Heat StimPlus is NUH.

Essais cliniques associés

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Dispositifs connexes (Code : NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

Source officielle

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