FDA 510(k)

Painmaster MCT Patch

K-Nummer: K151995 · 2016-10-05

Entscheidungsdatum2016-10-05

ProduktcodeNUH

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

Painmaster MCT Patch is the device name listed in this FDA 510(k) record. The listed applicant is Newmark, Inc.. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K151995. 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 Painmaster MCT Patch?

Painmaster MCT Patch is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is Newmark, Inc.. The 510(k) number is K151995.

When did Painmaster MCT Patch receive FDA 510(k) clearance?

Painmaster MCT Patch received FDA 510(k) clearance on 2016-10-05, under 510(k) number K151995.

Who is the listed applicant for Painmaster MCT Patch?

The FDA 510(k) record lists Newmark, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Painmaster MCT Patch?

The FDA product code for Painmaster MCT Patch 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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