Cleared Traditional

K822783 - FLEX ICE FREEZE PACK

K822783 is an FDA 510(k) clearance for FLEX ICE FREEZE PACK, manufactured by Igloo Corp.. The device is a Class 1 Physical Medicine device with product code IME cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K822783 · Igloo Corp. · Physical Medicine device

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Oct 1982

Decision

22d

Days

Class 1

Risk

K822783 is an FDA 510(k) clearance for the FLEX ICE FREEZE PACK. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Igloo Corp. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5700 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K822783

510(k) Number	K822783 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 14, 1982
Decision Date	October 06, 1982
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

94d faster than avg

Panel avg: 116d · This submission: 22d

Pathway characteristics

Predicate-based equivalence.

IME Device Classification - Class 1, General Controls

Product Code	IME Pack, Hot Or Cold, Reusable
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 890.5700

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IME Pack, Hot Or Cold, Reusable

All 21

Devices cleared under the same product code (IME) and FDA review panel - the closest regulatory comparables to K822783.

THERMOELASTOMER HOT/COLD COMPRESS BK7186

K823649 · Fred Sammons, Inc. · Jan 1983

THERMOELASTOMER HOT/COLD COMPRESS-7187-

K823650 · Fred Sammons, Inc. · Jan 1983

HOT/COLD PACK HOLDERS

K823814 · Danek Medical, Inc. · Jan 1983

ATTACH-A-PAK

K821636 · Fred Sammons, Inc. · Jun 1982

COLD ROLL

K820901 · North Bank Labs, Inc. · Apr 1982

COLD-HOT PACK

K820068 · Hospital Marketing Services Co., Inc. · Jan 1982

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K822783

Igloo Corp.

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Igloo Corp. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: October 6, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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