Product Code: IME FDA class 1 21 CFR 890.5700

Pack, Hot Or Cold, Reusable

Physical Medicine

A Reusable Hot or Cold Pack is a Physical Medicine thermal therapy device designed for repeated use, typically filled with a gel or granular material that retains temperature after heating or freezing, applied to the body for localized heat or cold therapy to relieve pain and reduce inflammation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IME, regulated under 21 CFR 890.5700, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

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510(k)s

FEI Numbers

467

Registration Numbers

468

Unique Applicants

Years Active

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Basic Information

Product Code: IME
Device Class: FDA class 1
Regulation Number: 890.5700
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K923627	COLD PACK	Apr 14, 1993	Substantially Equivalent	Friendmed Products
K915876	HOTPAD	Feb 12, 1993	Substantially Equivalent	Ten Comfort Corp.
K921446	HOT OR COLD PACK (THERMIPAQ)	Jul 13, 1992	Substantially Equivalent	Thermionics Corp.
K905207	MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS	Jan 22, 1991	Substantially Equivalent for Some Indications	Micro Surgical Instruments Corp.
K882413	SUBOCCIPITAL ICE PILLOW	Nov 30, 1988	Substantially Equivalent	Ferguson Medical
K863654	RE-HEATER, HOT PACK	Oct 23, 1986	Substantially Equivalent	K & L Ent.
K832193	NICE PACK	Aug 31, 1983	Substantially Equivalent	Universal Medical Instrument Corp.
K831899	ENSWELL	Jul 07, 1983	Substantially Equivalent	Dr. Micheal A. Sabia
K830981	MICROPAK MOIST HEAT PAD	Jun 03, 1983	Substantially Equivalent	Micropak Manufacturers, Inc.
K830416	ICY COLD ICE CAP	Mar 10, 1983	Substantially Equivalent	Ladora Ent.
K823650	THERMOELASTOMER HOT/COLD COMPRESS-7187-	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823649	THERMOELASTOMER HOT/COLD COMPRESS BK7186	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823814	HOT/COLD PACK HOLDERS	Jan 14, 1983	Substantially Equivalent	Danek Medical, Inc.
K822783	FLEX ICE FREEZE PACK	Oct 06, 1982	Substantially Equivalent	Igloo Corp.
K821636	ATTACH-A-PAK	Jun 11, 1982	Substantially Equivalent	Fred Sammons, Inc.
K820901	COLD ROLL	Apr 15, 1982	Substantially Equivalent	North Bank Labs, Inc.
K820068	COLD-HOT PACK	Jan 28, 1982	Substantially Equivalent	Hospital Marketing Services Co., Inc.
K810451	REUSEABLE HOT & COLD PACKS	Mar 04, 1981	Substantially Equivalent	Fred Sammons, Inc.
K810402	ACE COLD BANDAGE	Mar 04, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K803299	COLD/HOT PACK	Jan 15, 1981	Substantially Equivalent	W.G. Whitney Corp.
K801776	COLD PACK #589	Aug 07, 1980	Substantially Equivalent	Sunbeam Corp.
K801365	KOLD WRAP	Aug 07, 1980	Substantially Equivalent	Romaine, Inc.
K800917	TRU-COLD THERAPY PAK	May 02, 1980	Substantially Equivalent	Tru-Eze Mfg. Co., Inc.
K792182	ICE CONTAINER I.C.E.	Nov 15, 1979	Substantially Equivalent	Delta Medical Industries
K791684	WARM-EE HEAT PACK	Oct 30, 1979	Substantially Equivalent	U.S. Export Marketing Group, Inc.
K790009	ICE PACK, REUSABLE FLEXIBLE	Jan 22, 1979	Substantially Equivalent	Ackrad Laboratories
K771002	ICE BAND	Aug 30, 1977	Substantially Equivalent	Norcliff Thayer, Inc.