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FDA 510(k)

SOOTHIES GEL PADS

K-Number: K052858 · 2006-02-09

ApplicantPuronxy, Inc.
Decision Date2006-02-09
Product CodeNXH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOOTHIES GEL PADS is the device name listed in this FDA 510(k) record. The listed applicant is Puronxy, Inc.. It received FDA 510(k) clearance on 2006-02-09 under 510(k) number K052858. The device is classified under product code NXH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOOTHIES GEL PADS?

SOOTHIES GEL PADS is a medical device that received FDA 510(k) clearance on 2006-02-09. The listed applicant is Puronxy, Inc.. The 510(k) number is K052858.

When did SOOTHIES GEL PADS receive FDA 510(k) clearance?

SOOTHIES GEL PADS received FDA 510(k) clearance on 2006-02-09, under 510(k) number K052858.

Who is the listed applicant for SOOTHIES GEL PADS?

The FDA 510(k) record lists Puronxy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOOTHIES GEL PADS?

The FDA product code for SOOTHIES GEL PADS is NXH.

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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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