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FDA 510(k)

Perfect EMS

K-Number: K200694 · 2021-06-04

ApplicantTenscare, Ltd.
Decision Date2021-06-04
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Perfect EMS is a medical device manufactured by Tenscare, Ltd.. It received FDA 510(k) clearance on 2021-06-04 under approval number K200694. 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 Perfect EMS?

Perfect EMS is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Tenscare, Ltd.. The 510(k) number is K200694.

When was Perfect EMS approved by the FDA?

Perfect EMS received FDA 510(k) clearance on 2021-06-04, under approval number K200694.

What company makes Perfect EMS?

Perfect EMS is manufactured by Tenscare, Ltd..

What is the FDA product code for Perfect EMS?

The FDA product code for Perfect EMS is NUH.

Other Devices by Tenscare, Ltd.

K191312Perfect PFE K230926Ova+ (K-OVAP-USA) K230983Unicare (K-UNICARE-USA) K231053Unicare (K-UNICARE-USA) K232441Unipro (K-UNIPRO-US)

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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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