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FDA 510(k)

Low-frequency Stimulator (Model: AST-645, AST-646)

K-Number: K212989 · 2021-11-22

ApplicantShenzhen Osto Technology Co., Ltd.
Decision Date2021-11-22
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Low-frequency Stimulator (Model: AST-645, AST-646) is a medical device manufactured by Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-22 under approval number K212989. 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 Low-frequency Stimulator (Model: AST-645, AST-646)?

Low-frequency Stimulator (Model: AST-645, AST-646) is a medical device that received FDA 510(k) clearance on 2021-11-22. It is manufactured by Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K212989.

When was Low-frequency Stimulator (Model: AST-645, AST-646) approved by the FDA?

Low-frequency Stimulator (Model: AST-645, AST-646) received FDA 510(k) clearance on 2021-11-22, under approval number K212989.

What company makes Low-frequency Stimulator (Model: AST-645, AST-646)?

Low-frequency Stimulator (Model: AST-645, AST-646) is manufactured by Shenzhen Osto Technology Co., Ltd..

What is the FDA product code for Low-frequency Stimulator (Model: AST-645, AST-646)?

The FDA product code for Low-frequency Stimulator (Model: AST-645, AST-646) is NUH.

Other Devices by Shenzhen Osto Technology Co., Ltd.

K172897Neck Care Therapy, Model: SYK 509B K172837Low-frequency Multi-function physiotherapy instrument K172834Dual output digital therapy massager K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

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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