FDA 510(k)

TinniLogic Mobile Tinnitus Management Device

Numéro K : K163094 · 2017-05-17

DemandeurJiangsu Betterlife Medical Co., Ltd.

Date de décision2017-05-17

Code produitKLW

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

TinniLogic Mobile Tinnitus Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Betterlife Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K163094. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TinniLogic Mobile Tinnitus Management Device?

TinniLogic Mobile Tinnitus Management Device is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Jiangsu Betterlife Medical Co., Ltd.. The 510(k) number is K163094.

When did TinniLogic Mobile Tinnitus Management Device receive FDA 510(k) clearance?

TinniLogic Mobile Tinnitus Management Device received FDA 510(k) clearance on 2017-05-17, under 510(k) number K163094.

Who is the listed applicant for TinniLogic Mobile Tinnitus Management Device?

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

What is the FDA product code for TinniLogic Mobile Tinnitus Management Device?

The FDA product code for TinniLogic Mobile Tinnitus Management Device is KLW.

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 : KLW)

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical Corporation K260614Tinnitus TherapySivantos GmbH K233435Peace N Quiet (0.7.0)Pnq Health K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

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.