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FDA 510(k)

FLEX ICE FREEZE PACK

K-Number: K822783 · 1982-10-06

ApplicantIgloo Corp.
Decision Date1982-10-06
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FLEX ICE FREEZE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Igloo Corp.. It received FDA 510(k) clearance on 1982-10-06 under 510(k) number K822783. 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 FLEX ICE FREEZE PACK?

FLEX ICE FREEZE PACK is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is Igloo Corp.. The 510(k) number is K822783.

When did FLEX ICE FREEZE PACK receive FDA 510(k) clearance?

FLEX ICE FREEZE PACK received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822783.

Who is the listed applicant for FLEX ICE FREEZE PACK?

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

What is the FDA product code for FLEX ICE FREEZE PACK?

The FDA product code for FLEX ICE FREEZE PACK is IME.

Related Clinical Trials

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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.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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