FDA 510(k)

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13

K-Nummer: K162517 · 2017-04-14

Entscheidungsdatum2017-04-14

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is the device name listed in this FDA 510(k) record. The listed applicant is Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K162517. 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 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K162517.

When did Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 receive FDA 510(k) clearance?

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 received FDA 510(k) clearance on 2017-04-14, under 510(k) number K162517.

Who is the listed applicant for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

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

What is the FDA product code for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

The FDA product code for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 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 Jkh Health Co., Ltd. als Antragsteller

K253150Cryon-X Cold Compression K240788Ultrasound Stimulator K240986Cold Compression K240011Lymphedema Compression K223541Cold/Hot Compression K211050Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304

Alle 10 Geräte anzeigen →

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.