FDA 510(k)

Unicare (K-UNICARE-USA)

K-Number: K231053 · 2023-08-18

Decision Date2023-08-18

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Unicare (K-UNICARE-USA) is a medical device manufactured by Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-08-18 under approval number K231053. 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 Unicare (K-UNICARE-USA)?

Unicare (K-UNICARE-USA) is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Tenscare, Ltd.. The 510(k) number is K231053.

When was Unicare (K-UNICARE-USA) approved by the FDA?

Unicare (K-UNICARE-USA) received FDA 510(k) clearance on 2023-08-18, under approval number K231053.

What company makes Unicare (K-UNICARE-USA)?

Unicare (K-UNICARE-USA) is manufactured by Tenscare, Ltd..

What is the FDA product code for Unicare (K-UNICARE-USA)?

The FDA product code for Unicare (K-UNICARE-USA) is NUH.

Other Devices by Tenscare, Ltd.

K191312Perfect PFE K200694Perfect EMS K230926Ova+ (K-OVAP-USA) K230983Unicare (K-UNICARE-USA) K232441Unipro (K-UNIPRO-US)

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.