FDA 510(k)

Health Expert Electronic Stimulator (model: AST-300L)

K-Number: K190783 · 2020-03-14

ApplicantShenzhen Osto Technology Company Limited

Decision Date2020-03-14

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Health Expert Electronic Stimulator (model: AST-300L) is a medical device manufactured by Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2020-03-14 under approval number K190783. 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 Health Expert Electronic Stimulator (model: AST-300L)?

Health Expert Electronic Stimulator (model: AST-300L) is a medical device that received FDA 510(k) clearance on 2020-03-14. It is manufactured by Shenzhen Osto Technology Company Limited. The 510(k) number is K190783.

When was Health Expert Electronic Stimulator (model: AST-300L) approved by the FDA?

Health Expert Electronic Stimulator (model: AST-300L) received FDA 510(k) clearance on 2020-03-14, under approval number K190783.

What company makes Health Expert Electronic Stimulator (model: AST-300L)?

Health Expert Electronic Stimulator (model: AST-300L) is manufactured by Shenzhen Osto Technology Company Limited.

What is the FDA product code for Health Expert Electronic Stimulator (model: AST-300L)?

The FDA product code for Health Expert Electronic Stimulator (model: AST-300L) is NUH.

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Related PubMed Literature

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Other Devices by Shenzhen Osto Technology Company Limited

K190673Health Expert Electronic Stimulator K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H K213056LED Facial Mask

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

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