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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 a medical device manufactured by Wat Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-02-26 under approval 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. It is manufactured by Wat Medical Technology, Inc.. The 510(k) number is K230782.

When was TENS device-HeadaTerm 2 (Model: YF-HT2) approved by the FDA?

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

What company makes TENS device-HeadaTerm 2 (Model: YF-HT2)?

TENS device-HeadaTerm 2 (Model: YF-HT2) is manufactured by Wat Medical Technology, Inc..

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.

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

Other Devices by Wat Medical Technology, Inc.

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

Related Devices (Code: PCC)

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Official Source

View on FDA Database →

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

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