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FDA 510(k)

TRU-COLD THERAPY PAK

K-Number: K800917 · 1980-05-02

ApplicantTru-Eze Mfg. Co., Inc.
Decision Date1980-05-02
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRU-COLD THERAPY PAK is the device name listed in this FDA 510(k) record. The listed applicant is Tru-Eze Mfg. Co., Inc.. It received FDA 510(k) clearance on 1980-05-02 under 510(k) number K800917. The device is classified under product code IME. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRU-COLD THERAPY PAK?

TRU-COLD THERAPY PAK is a medical device that received FDA 510(k) clearance on 1980-05-02. The listed applicant is Tru-Eze Mfg. Co., Inc.. The 510(k) number is K800917.

When did TRU-COLD THERAPY PAK receive FDA 510(k) clearance?

TRU-COLD THERAPY PAK received FDA 510(k) clearance on 1980-05-02, under 510(k) number K800917.

Who is the listed applicant for TRU-COLD THERAPY PAK?

The FDA 510(k) record lists Tru-Eze Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRU-COLD THERAPY PAK?

The FDA product code for TRU-COLD THERAPY PAK is IME.

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.

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Other records listing Tru-Eze Mfg. Co., Inc. 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.

K801625THERMOLATOR HEATING UNITK791653REUSABLE MOIST HEAT PACK

Related Devices (Code: IME)

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.

K923627COLD PACKFriendmed ProductsK915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson MedicalK863654RE-HEATER, HOT PACKK & L Ent.

Official Source

View on FDA Database →

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

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