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FDA 510(k)

Smart Pain Reliever, Model LT5019

K-Number: K162479 · 2017-02-08

Decision Date2017-02-08
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Smart Pain Reliever, Model LT5019 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K162479. 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 Smart Pain Reliever, Model LT5019?

Smart Pain Reliever, Model LT5019 is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K162479.

When did Smart Pain Reliever, Model LT5019 receive FDA 510(k) clearance?

Smart Pain Reliever, Model LT5019 received FDA 510(k) clearance on 2017-02-08, under 510(k) number K162479.

Who is the listed applicant for Smart Pain Reliever, Model LT5019?

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

What is the FDA product code for Smart Pain Reliever, Model LT5019?

The FDA product code for Smart Pain Reliever, Model LT5019 is NUH.

Other records listing Shenzhen Dongdixin Technology 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.

View all 10 devices →

Related Devices (Code: NUH)

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.

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.