FDA 510(k)

OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)

K-Number: K130802 · 2013-09-16

ApplicantShenzhen Dongdixin Technology Co., Ltd.

Decision Date2013-09-16

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2013-09-16 under 510(k) number K130802. 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 OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)?

OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) is a medical device that received FDA 510(k) clearance on 2013-09-16. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K130802.

When did OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) receive FDA 510(k) clearance?

OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) received FDA 510(k) clearance on 2013-09-16, under 510(k) number K130802.

Who is the listed applicant for OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)?

The FDA product code for OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) is NUH.

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Other records listing Shenzhen Dongdixin Technology Co., Ltd. as applicant

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Related Devices (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.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.