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FDA 510(k)

N5-1

K-Number: K153054 · 2016-02-05

ApplicantNuga Medical Co., Ltd.
Decision Date2016-02-05
Product CodeJFB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

N5-1 is the device name listed in this FDA 510(k) record. The listed applicant is Nuga Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K153054. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N5-1?

N5-1 is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Nuga Medical Co., Ltd.. The 510(k) number is K153054.

When did N5-1 receive FDA 510(k) clearance?

N5-1 received FDA 510(k) clearance on 2016-02-05, under 510(k) number K153054.

Who is the listed applicant for N5-1?

The FDA 510(k) record lists Nuga Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N5-1?

The FDA product code for N5-1 is JFB.

Other records listing Nuga Medical Co., Ltd. as applicant

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.

K240168N7-S

Related Devices (Code: JFB)

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.

K250266Ceragem Automatic Thermal Massager (CGM MB-2401)Ceragem Co., Ltd.K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)Marzzan Lucas JorgeK243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)Ceragem Co., Ltd.K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd.K240168N7-SNuga Medical Co., Ltd.K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd.

Official Source

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

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