FDA 510(k)

Portable Electro-Stimulation Therapy Device

K-Nummer: K182108 · 2019-04-26

AntragstellerGuangzhou Longest Science & Technology Co., Ltd.

Entscheidungsdatum2019-04-26

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Portable Electro-Stimulation Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-04-26 under 510(k) number K182108. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Portable Electro-Stimulation Therapy Device?

Portable Electro-Stimulation Therapy Device is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. The 510(k) number is K182108.

When did Portable Electro-Stimulation Therapy Device receive FDA 510(k) clearance?

Portable Electro-Stimulation Therapy Device received FDA 510(k) clearance on 2019-04-26, under 510(k) number K182108.

Who is the listed applicant for Portable Electro-Stimulation Therapy Device?

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

What is the FDA product code for Portable Electro-Stimulation Therapy Device?

The FDA product code for Portable Electro-Stimulation Therapy Device is NUH.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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

Weitere Einträge mit Guangzhou Longest Science & Technology Co., Ltd. als Antragsteller

K202110MStim Drop Model: LGT-233 K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)K182020Portable Electro-Stimulation Therapy Device K191856Compression Therapy Device K191862Compression Therapy Device Model LGT-2200SP

Verwandte Geräte (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

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.