Cleared Traditional

K811206 - SELF HEATING DISPOSABLE HEAT PAD

K811206 is an FDA 510(k) clearance for SELF HEATING DISPOSABLE HEAT PAD, manufactured by Ensar Corp.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K811206 · Ensar Corp. · Physical Medicine device
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May 1981
Decision
20d
Days
Class 1
Risk

K811206 is an FDA 510(k) clearance for the SELF HEATING DISPOSABLE HEAT PAD. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Ensar Corp. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - 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 - K811206

510(k) Number K811206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1981
Decision Date May 21, 1981
Days to Decision 20 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
96d faster than avg
Panel avg: 116d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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 - IMD Pack, Hot Or Cold, Disposable

All 77
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K811206.
ACE BRAND INSTANT COLD PACK
K820282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1982
BK-7182 INSTANT COLD PACK
K813628 · Fred Sammons, Inc. · Jan 1982
JAPANESE HOTZIE
K811803 · Consolidated Health & Sports Prod. · Jul 1981
WONDER WARMER
K810633 · Montvale Products, Inc. · Mar 1981
CURITY PERINEAL WARM PACK
K810692 · The Kendal Co. · Mar 1981
CURITY PERINEAL COLD PACK
K810693 · The Kendal Co. · Mar 1981
K811206 · SELF HEATING DISPOSABLE HEAT PAD
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