Cleared Traditional

K830416 - ICY COLD ICE CAP

K830416 is an FDA 510(k) clearance for ICY COLD ICE CAP, manufactured by Ladora Ent.. The device is a Class 1 Physical Medicine device with product code IME cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K830416 · Ladora Ent. · Physical Medicine device
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Mar 1983
Decision
30d
Days
Class 1
Risk

K830416 is an FDA 510(k) clearance for the ICY COLD ICE CAP. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Ladora Ent. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1983 after a review of 30 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 - K830416

510(k) Number K830416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1983
Decision Date March 10, 1983
Days to Decision 30 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
86d faster than avg
Panel avg: 116d · This submission: 30d
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 K830416.
NICE PACK
K832193 · Universal Medical Instrument Corp. · Aug 1983
ENSWELL
K831899 · Dr. Micheal A. Sabia · Jul 1983
MICROPAK MOIST HEAT PAD
K830981 · Micropak Manufacturers, Inc. · Jun 1983
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
K830416 · ICY COLD ICE CAP
Download PDF Ladora Ent.