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FDA 510(k)

SMARTRELIEF

K-Number: K131159 · 2013-07-25

ApplicantChattem, Inc.
Decision Date2013-07-25
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMARTRELIEF is the device name listed in this FDA 510(k) record. The listed applicant is Chattem, Inc.. It received FDA 510(k) clearance on 2013-07-25 under 510(k) number K131159. 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 SMARTRELIEF?

SMARTRELIEF is a medical device that received FDA 510(k) clearance on 2013-07-25. The listed applicant is Chattem, Inc.. The 510(k) number is K131159.

When did SMARTRELIEF receive FDA 510(k) clearance?

SMARTRELIEF received FDA 510(k) clearance on 2013-07-25, under 510(k) number K131159.

Who is the listed applicant for SMARTRELIEF?

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

What is the FDA product code for SMARTRELIEF?

The FDA product code for SMARTRELIEF 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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