FDA 510(k)

Tyece OTC TENS Model

Numéro K : K200838 · 2020-08-12

Date de décision2020-08-12

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Tyece OTC TENS Model is the device name listed in this FDA 510(k) record. The listed applicant is Tyece Limited. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K200838. 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 Tyece OTC TENS Model?

Tyece OTC TENS Model is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Tyece Limited. The 510(k) number is K200838.

When did Tyece OTC TENS Model receive FDA 510(k) clearance?

Tyece OTC TENS Model received FDA 510(k) clearance on 2020-08-12, under 510(k) number K200838.

Who is the listed applicant for Tyece OTC TENS Model?

The FDA 510(k) record lists Tyece Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyece OTC TENS Model?

The FDA product code for Tyece OTC TENS Model 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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