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FDA 510(k)

EMS Belt (Model MC0485)

K-Number: K183103 · 2019-09-18

ApplicantDongguan Yingfeng Metal & Plastic Products Co., Ltd.
Decision Date2019-09-18
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMS Belt (Model MC0485) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Yingfeng Metal & Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K183103. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMS Belt (Model MC0485)?

EMS Belt (Model MC0485) is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Dongguan Yingfeng Metal & Plastic Products Co., Ltd.. The 510(k) number is K183103.

When did EMS Belt (Model MC0485) receive FDA 510(k) clearance?

EMS Belt (Model MC0485) received FDA 510(k) clearance on 2019-09-18, under 510(k) number K183103.

Who is the listed applicant for EMS Belt (Model MC0485)?

The FDA 510(k) record lists Dongguan Yingfeng Metal & Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMS Belt (Model MC0485)?

The FDA product code for EMS Belt (Model MC0485) is NGX.

Related Devices (Code: NGX)

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.

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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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