FDA 510(k)

Electronic Pulse Stimulator

K-Nummer: K183674 · 2019-10-11

AntragstellerShenzhen Leading Perfection Technology Co., Ltd.

Entscheidungsdatum2019-10-11

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Electronic Pulse Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leading Perfection Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K183674. 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?

Electronic Pulse Stimulator is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Shenzhen Leading Perfection Technology Co., Ltd.. The 510(k) number is K183674.

When did Electronic Pulse Stimulator receive FDA 510(k) clearance?

Electronic Pulse Stimulator received FDA 510(k) clearance on 2019-10-11, under 510(k) number K183674.

Who is the listed applicant for Electronic Pulse Stimulator?

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

What is the FDA product code for Electronic Pulse Stimulator?

The FDA product code for Electronic Pulse Stimulator is NUH.

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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

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