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FDA 510(k)

ELECTRONIC PULSE MASSAGER

K-Number: K131933 · 2013-12-20

ApplicantGurin Products, LLC
Decision Date2013-12-20
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC PULSE MASSAGER is the device name listed in this FDA 510(k) record. The listed applicant is Gurin Products, LLC. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K131933. 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 ELECTRONIC PULSE MASSAGER?

ELECTRONIC PULSE MASSAGER is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Gurin Products, LLC. The 510(k) number is K131933.

When did ELECTRONIC PULSE MASSAGER receive FDA 510(k) clearance?

ELECTRONIC PULSE MASSAGER received FDA 510(k) clearance on 2013-12-20, under 510(k) number K131933.

Who is the listed applicant for ELECTRONIC PULSE MASSAGER?

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

What is the FDA product code for ELECTRONIC PULSE MASSAGER?

The FDA product code for ELECTRONIC PULSE MASSAGER is NUH.

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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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