FDA 510(k)

HBOTC Muscle and Nerve Stimulator

Numéro K : K160255 · 2016-09-15

Date de décision2016-09-15

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

HBOTC Muscle and Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Hb Medical, Inc.. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K160255. 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 HBOTC Muscle and Nerve Stimulator?

HBOTC Muscle and Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Hb Medical, Inc.. The 510(k) number is K160255.

When did HBOTC Muscle and Nerve Stimulator receive FDA 510(k) clearance?

HBOTC Muscle and Nerve Stimulator received FDA 510(k) clearance on 2016-09-15, under 510(k) number K160255.

Who is the listed applicant for HBOTC Muscle and Nerve Stimulator?

The FDA 510(k) record lists Hb Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HBOTC Muscle and Nerve Stimulator?

The FDA product code for HBOTC Muscle and Nerve Stimulator is NUH.

Essais cliniques associés

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Système d'évaluation du cathéter Uro-Cam assisté par intelligence artificielle pour le diagnostic du cancer de la vessieNOT_YET_RECRUITING

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

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.