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FDA 510(k)

TENS & EMS DEVICE (Model: FM-B2403A)

K-Number: K213741 · 2022-03-08

ApplicantShenzhen Jian Feng Electronic Technology Co., Ltd.
Decision Date2022-03-08
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS & EMS DEVICE (Model: FM-B2403A) is a medical device manufactured by Shenzhen Jian Feng Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-08 under approval number K213741. 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 TENS & EMS DEVICE (Model: FM-B2403A)?

TENS & EMS DEVICE (Model: FM-B2403A) is a medical device that received FDA 510(k) clearance on 2022-03-08. It is manufactured by Shenzhen Jian Feng Electronic Technology Co., Ltd.. The 510(k) number is K213741.

When was TENS & EMS DEVICE (Model: FM-B2403A) approved by the FDA?

TENS & EMS DEVICE (Model: FM-B2403A) received FDA 510(k) clearance on 2022-03-08, under approval number K213741.

What company makes TENS & EMS DEVICE (Model: FM-B2403A)?

TENS & EMS DEVICE (Model: FM-B2403A) is manufactured by Shenzhen Jian Feng Electronic Technology Co., Ltd..

What is the FDA product code for TENS & EMS DEVICE (Model: FM-B2403A)?

The FDA product code for TENS & EMS DEVICE (Model: FM-B2403A) is NUH.

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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 Shenzhen Jian Feng Electronic Technology Co., Ltd.

K202866TENS & EMS Device K213835TENS & EMS Device K223825Tens & Ems Device

Related Devices (Code: NUH)

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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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