FDA 510(k)

MHD TENS

Numéro K : K190115 · 2019-06-19

DemandeurMinghuangda Electronic Co., Ltd.

Date de décision2019-06-19

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

MHD TENS is the device name listed in this FDA 510(k) record. The listed applicant is Minghuangda Electronic Co., Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K190115. 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 MHD TENS?

MHD TENS is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Minghuangda Electronic Co., Ltd.. The 510(k) number is K190115.

When did MHD TENS receive FDA 510(k) clearance?

MHD TENS received FDA 510(k) clearance on 2019-06-19, under 510(k) number K190115.

Who is the listed applicant for MHD TENS?

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

What is the FDA product code for MHD TENS?

The FDA product code for MHD TENS is NUH.

Dispositifs connexes (Code : NUH)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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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