FDA 510(k)

Digital TENS Unit

Numéro K : K170145 · 2017-04-29

DemandeurShenzhen Eapply Technology Co., Ltd.

Date de décision2017-04-29

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Digital TENS Unit is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Eapply Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-29 under 510(k) number K170145. 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 Digital TENS Unit?

Digital TENS Unit is a medical device that received FDA 510(k) clearance on 2017-04-29. The listed applicant is Shenzhen Eapply Technology Co., Ltd.. The 510(k) number is K170145.

When did Digital TENS Unit receive FDA 510(k) clearance?

Digital TENS Unit received FDA 510(k) clearance on 2017-04-29, under 510(k) number K170145.

Who is the listed applicant for Digital TENS Unit?

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

What is the FDA product code for Digital TENS Unit?

The FDA product code for Digital TENS Unit 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 NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_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.