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FDA 510(k)

TENS and Muscle Stimulator

K-Number: K200727 · 2020-06-18

ApplicantShenzhen Astec Technology Co., Ltd.
Decision Date2020-06-18
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS and Muscle Stimulator is a medical device manufactured by Shenzhen Astec Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-18 under approval number K200727. 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 and Muscle Stimulator?

TENS and Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Shenzhen Astec Technology Co., Ltd.. The 510(k) number is K200727.

When was TENS and Muscle Stimulator approved by the FDA?

TENS and Muscle Stimulator received FDA 510(k) clearance on 2020-06-18, under approval number K200727.

What company makes TENS and Muscle Stimulator?

TENS and Muscle Stimulator is manufactured by Shenzhen Astec Technology Co., Ltd..

What is the FDA product code for TENS and Muscle Stimulator?

The FDA product code for TENS and Muscle Stimulator is NUH.

Related Clinical Trials

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Other Devices by Shenzhen Astec Technology Co., Ltd.

K243856TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)

Related Devices (Code: NUH)

K162630CP Relief Wand-OTCMid-America Medical Innovations, LLC K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited K160508Electronic Pulse StimulatorBeijing Choice Electronic Technololgy Co., Ltd. K161537OTC TENS Device, Model PTS-IVCounter Scientific Development (Gz), Ltd. K151995Painmaster MCT PatchNewmark, Inc. K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc.

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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