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FDA 510(k)

EMS/TENS Massager Device

K-Number: K233040 · 2024-02-12

Decision Date2024-02-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMS/TENS Massager Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233040. 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 EMS/TENS Massager Device?

EMS/TENS Massager Device is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Shenzhen Imdk Medical Technology Co., Ltd.. The 510(k) number is K233040.

When did EMS/TENS Massager Device receive FDA 510(k) clearance?

EMS/TENS Massager Device received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233040.

Who is the listed applicant for EMS/TENS Massager Device?

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

What is the FDA product code for EMS/TENS Massager Device?

The FDA product code for EMS/TENS Massager Device is NUH.

Other records listing Shenzhen Imdk 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 7 devices →

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