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FDA 510(k)

Microcurrent device (Model: HBR2-1)

K-Number: K211055 · 2021-11-05

ApplicantShenzhen DJ Medical Equipment Co., Ltd.
Decision Date2021-11-05
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Microcurrent device (Model: HBR2-1) is a medical device manufactured by Shenzhen DJ Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-11-05 under approval number K211055. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microcurrent device (Model: HBR2-1)?

Microcurrent device (Model: HBR2-1) is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Shenzhen DJ Medical Equipment Co., Ltd.. The 510(k) number is K211055.

When was Microcurrent device (Model: HBR2-1) approved by the FDA?

Microcurrent device (Model: HBR2-1) received FDA 510(k) clearance on 2021-11-05, under approval number K211055.

What company makes Microcurrent device (Model: HBR2-1)?

Microcurrent device (Model: HBR2-1) is manufactured by Shenzhen DJ Medical Equipment Co., Ltd..

What is the FDA product code for Microcurrent device (Model: HBR2-1)?

The FDA product code for Microcurrent device (Model: HBR2-1) is NFO.

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Related PubMed Literature

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: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023) PMID: 36103178 Estimated Cost of Developing a Therapeutic Complex Medical Device in the US. JAMA network open (2022)

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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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