FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)

Numéro K : K231425 · 2024-03-27

DemandeurWuxi Jiajian Medical Instrument Co., Ltd.

Date de décision2024-03-27

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K231425. 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 Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)?

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. The 510(k) number is K231425.

When did Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) received FDA 510(k) clearance on 2024-03-27, under 510(k) number K231425.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)?

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

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) 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

Autres dossiers indiquant Wuxi Jiajian Medical Instrument Co., Ltd. en tant que demandeur

K244030Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)K202861Needle Stimulator K202893Transcutaneous Electrical Nerve Stimulator K192568Jiajian Self-Adhesive Electrode

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.