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FDA 510(k)

TENS device-HeadaTerm 2 (Model: YF-HT2)

K-Number: K230782 · 2024-02-26

ApplicantWat Medical Technology, Inc.
Decision Date2024-02-26
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS device-HeadaTerm 2 (Model: YF-HT2) is the device name listed in this FDA 510(k) record. The listed applicant is Wat Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-02-26 under 510(k) number K230782. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS device-HeadaTerm 2 (Model: YF-HT2)?

TENS device-HeadaTerm 2 (Model: YF-HT2) is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Wat Medical Technology, Inc.. The 510(k) number is K230782.

When did TENS device-HeadaTerm 2 (Model: YF-HT2) receive FDA 510(k) clearance?

TENS device-HeadaTerm 2 (Model: YF-HT2) received FDA 510(k) clearance on 2024-02-26, under 510(k) number K230782.

Who is the listed applicant for TENS device-HeadaTerm 2 (Model: YF-HT2)?

The FDA 510(k) record lists Wat Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS device-HeadaTerm 2 (Model: YF-HT2)?

The FDA product code for TENS device-HeadaTerm 2 (Model: YF-HT2) is PCC.

Other records listing Wat Medical Technology, Inc. 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.

K220503TENS device-EmeTerm 2, Model: YF-ZTY-E2

Related Devices (Code: PCC)

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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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