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FDA 510(k)

HOT OR COLD PACK (THERMIPAQ)

K-Number: K921446 · 1992-07-13

ApplicantThermionics Corp.
Decision Date1992-07-13
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOT OR COLD PACK (THERMIPAQ) is the device name listed in this FDA 510(k) record. The listed applicant is Thermionics Corp.. It received FDA 510(k) clearance on 1992-07-13 under 510(k) number K921446. 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 HOT OR COLD PACK (THERMIPAQ)?

HOT OR COLD PACK (THERMIPAQ) is a medical device that received FDA 510(k) clearance on 1992-07-13. The listed applicant is Thermionics Corp.. The 510(k) number is K921446.

When did HOT OR COLD PACK (THERMIPAQ) receive FDA 510(k) clearance?

HOT OR COLD PACK (THERMIPAQ) received FDA 510(k) clearance on 1992-07-13, under 510(k) number K921446.

Who is the listed applicant for HOT OR COLD PACK (THERMIPAQ)?

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

What is the FDA product code for HOT OR COLD PACK (THERMIPAQ)?

The FDA product code for HOT OR COLD PACK (THERMIPAQ) 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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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.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson MedicalK863654RE-HEATER, HOT PACKK & L Ent.K832193NICE PACKUniversal Medical Instrument Corp.

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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