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FDA 510(k)

PRO-CHILL STIMPACK

K-Number: K912210 · 1992-11-27

ApplicantTko, Inc.
Decision Date1992-11-27
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PRO-CHILL STIMPACK is the device name listed in this FDA 510(k) record. The listed applicant is Tko, Inc.. It received FDA 510(k) clearance on 1992-11-27 under 510(k) number K912210. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-CHILL STIMPACK?

PRO-CHILL STIMPACK is a medical device that received FDA 510(k) clearance on 1992-11-27. The listed applicant is Tko, Inc.. The 510(k) number is K912210.

When did PRO-CHILL STIMPACK receive FDA 510(k) clearance?

PRO-CHILL STIMPACK received FDA 510(k) clearance on 1992-11-27, under 510(k) number K912210.

Who is the listed applicant for PRO-CHILL STIMPACK?

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

What is the FDA product code for PRO-CHILL STIMPACK?

The FDA product code for PRO-CHILL STIMPACK is GXY.

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Official Source

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