FDA 510(k)

WARM-EE HEAT PACK

K-Number: K791684 · 1979-10-30

ApplicantU.S. Export Marketing Group, Inc.

Decision Date1979-10-30

Product CodeIME

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

WARM-EE HEAT PACK is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Export Marketing Group, Inc.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K791684. 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 WARM-EE HEAT PACK?

WARM-EE HEAT PACK is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is U.S. Export Marketing Group, Inc.. The 510(k) number is K791684.

When did WARM-EE HEAT PACK receive FDA 510(k) clearance?

WARM-EE HEAT PACK received FDA 510(k) clearance on 1979-10-30, under 510(k) number K791684.

Who is the listed applicant for WARM-EE HEAT PACK?

The FDA 510(k) record lists U.S. Export Marketing Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WARM-EE HEAT PACK?

The FDA product code for WARM-EE HEAT PACK is IME.

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 Products K915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson Medical K863654RE-HEATER, HOT PACKK & L Ent.

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.