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FDA 510(k)

TENS BACK PAIN RELIEF SYSTEM

K-Number: K113321 · 2012-09-04

ApplicantSavia Limited
Decision Date2012-09-04
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS BACK PAIN RELIEF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Savia Limited. It received FDA 510(k) clearance on 2012-09-04 under 510(k) number K113321. 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 TENS BACK PAIN RELIEF SYSTEM?

TENS BACK PAIN RELIEF SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-04. The listed applicant is Savia Limited. The 510(k) number is K113321.

When did TENS BACK PAIN RELIEF SYSTEM receive FDA 510(k) clearance?

TENS BACK PAIN RELIEF SYSTEM received FDA 510(k) clearance on 2012-09-04, under 510(k) number K113321.

Who is the listed applicant for TENS BACK PAIN RELIEF SYSTEM?

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

What is the FDA product code for TENS BACK PAIN RELIEF SYSTEM?

The FDA product code for TENS BACK PAIN RELIEF SYSTEM 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

View on FDA Database →

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

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