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FDA 510(k)

OTC TENS & EMS Unit

K-Number: K243511 · 2025-02-10

Decision Date2025-02-10
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OTC TENS & EMS Unit is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-10 under 510(k) number K243511. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTC TENS & EMS Unit?

OTC TENS & EMS Unit is a medical device that received FDA 510(k) clearance on 2025-02-10. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K243511.

When did OTC TENS & EMS Unit receive FDA 510(k) clearance?

OTC TENS & EMS Unit received FDA 510(k) clearance on 2025-02-10, under 510(k) number K243511.

Who is the listed applicant for OTC TENS & EMS Unit?

The FDA 510(k) record lists Changsha Anxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTC TENS & EMS Unit?

The FDA product code for OTC TENS & EMS Unit is NGX.

Other records listing Changsha Anxiang Medical 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.

View all 8 devices →

Related Devices (Code: NGX)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.