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FDA 510(k)

PAINMASTER MCT PATCH

K-Number: K090042 · 2009-05-06

ApplicantNewmark, Inc.
Decision Date2009-05-06
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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 2009-05-06 under 510(k) number K090042. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAINMASTER MCT PATCH?

PAINMASTER MCT PATCH is a medical device that received FDA 510(k) clearance on 2009-05-06. The listed applicant is Newmark, Inc.. The 510(k) number is K090042.

When did PAINMASTER MCT PATCH receive FDA 510(k) clearance?

PAINMASTER MCT PATCH received FDA 510(k) clearance on 2009-05-06, under 510(k) number K090042.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Newmark, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K151995Painmaster MCT PatchK130114PAINMASTER MCT PATCH

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.,LtdK260412TENS 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.K251958VEINOPLUS BackDynapulse Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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