FDA 510(k)

Unicare (K-UNICARE-USA)

K-Number: K230983 · 2023-10-20

Decision Date2023-10-20

Product CodeKPI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Unicare (K-UNICARE-USA) is a medical device manufactured by Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-10-20 under approval number K230983. The device is classified under product code KPI. It was reviewed by the GU 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 2023-10-20. It is manufactured by Tenscare, Ltd.. The 510(k) number is K230983.

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

Unicare (K-UNICARE-USA) received FDA 510(k) clearance on 2023-10-20, under approval number K230983.

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 KPI.

Other Devices by Tenscare, Ltd.

K191312Perfect PFE K200694Perfect EMS K230926Ova+ (K-OVAP-USA) K231053Unicare (K-UNICARE-USA) K232441Unipro (K-UNIPRO-US)

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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.