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FDA 510(k)

COOL/HEAT THERAPY APPLICATOR

K-Number: K944447 · 1995-02-09

Decision Date1995-02-09
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

COOL/HEAT THERAPY APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Science Technology, Inc.. It received FDA 510(k) clearance on 1995-02-09 under 510(k) number K944447. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the COOL/HEAT THERAPY APPLICATOR?

COOL/HEAT THERAPY APPLICATOR is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Medical Science Technology, Inc.. The 510(k) number is K944447.

When did COOL/HEAT THERAPY APPLICATOR receive FDA 510(k) clearance?

COOL/HEAT THERAPY APPLICATOR received FDA 510(k) clearance on 1995-02-09, under 510(k) number K944447.

Who is the listed applicant for COOL/HEAT THERAPY APPLICATOR?

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

What is the FDA product code for COOL/HEAT THERAPY APPLICATOR?

The FDA product code for COOL/HEAT THERAPY APPLICATOR is ILO.

Related Clinical Trials

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.

Related Devices (Code: ILO)

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.

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