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FDA 510(k)

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01

K-Number: K212377 · 2022-04-15

ApplicantNingbo Medkinetic Medical Device Co., Ltd.
Decision Date2022-04-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is a medical device manufactured by Ningbo Medkinetic Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-04-15 under approval number K212377. 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 Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is a medical device that received FDA 510(k) clearance on 2022-04-15. It is manufactured by Ningbo Medkinetic Medical Device Co., Ltd.. The 510(k) number is K212377.

When was Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 approved by the FDA?

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 received FDA 510(k) clearance on 2022-04-15, under approval number K212377.

What company makes Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is manufactured by Ningbo Medkinetic Medical Device Co., Ltd..

What is the FDA product code for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

The FDA product code for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is NUH.

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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.

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