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FDA 510(k)

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

K-Number: K220503 · 2022-04-23

ApplicantWat Medical Technology, Inc.
Decision Date2022-04-23
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS device-EmeTerm 2, Model: YF-ZTY-E2 is a medical device manufactured by Wat Medical Technology, Inc.. It received FDA 510(k) clearance on 2022-04-23 under approval number K220503. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS device-EmeTerm 2, Model: YF-ZTY-E2?

TENS device-EmeTerm 2, Model: YF-ZTY-E2 is a medical device that received FDA 510(k) clearance on 2022-04-23. It is manufactured by Wat Medical Technology, Inc.. The 510(k) number is K220503.

When was TENS device-EmeTerm 2, Model: YF-ZTY-E2 approved by the FDA?

TENS device-EmeTerm 2, Model: YF-ZTY-E2 received FDA 510(k) clearance on 2022-04-23, under approval number K220503.

What company makes TENS device-EmeTerm 2, Model: YF-ZTY-E2?

TENS device-EmeTerm 2, Model: YF-ZTY-E2 is manufactured by Wat Medical Technology, Inc..

What is the FDA product code for TENS device-EmeTerm 2, Model: YF-ZTY-E2?

The FDA product code for TENS device-EmeTerm 2, Model: YF-ZTY-E2 is GZJ.

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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.

K230782TENS device-HeadaTerm 2 (Model: YF-HT2)

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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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