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FDA 510(k)

Tens & Ems Device

K-Number: K223825 · 2023-05-09

Decision Date2023-05-09
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Tens & Ems Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jian Feng Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-09 under 510(k) number K223825. 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 Tens & Ems Device?

Tens & Ems Device is a medical device that received FDA 510(k) clearance on 2023-05-09. The listed applicant is Shenzhen Jian Feng Electronic Technology Co., Ltd.. The 510(k) number is K223825.

When did Tens & Ems Device receive FDA 510(k) clearance?

Tens & Ems Device received FDA 510(k) clearance on 2023-05-09, under 510(k) number K223825.

Who is the listed applicant for Tens & Ems Device?

The FDA 510(k) record lists Shenzhen Jian Feng Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tens & Ems Device?

The FDA product code for Tens & Ems Device is NUH.

Other records listing Shenzhen Jian Feng Electronic Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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