Cleared Traditional

K820469 - WARM & FORM KNEE SUPPORTS

K820469 is an FDA 510(k) clearance for WARM & FORM KNEE SUPPORTS, manufactured by Thermo-Mold Medical Products, Inc.. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K820469 · Thermo-Mold Medical Products, Inc. · Physical Medicine device
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Mar 1982
Decision
14d
Days
Class 1
Risk

K820469 is an FDA 510(k) clearance for the WARM & FORM KNEE SUPPORTS. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Thermo-Mold Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on March 8, 1982 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - 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 - K820469

510(k) Number K820469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1982
Decision Date March 08, 1982
Days to Decision 14 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
102d faster than avg
Panel avg: 116d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

IQI Device Classification - Class 1, General Controls

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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 - IQI Orthosis, Limb Brace

All 39
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K820469.
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982
WARM'N FORM SPORTS SUPPORTS
K821582 · Jerome Medical · Jun 1982
MULTITUBULAR AIR SPLINT KIT
K811704 · Roger Cestac & Assoc. · Jul 1981
ANKLE-FOOT CAST/SPLINT
K811690 · Surgical Appliance Industries, Inc. · Jun 1981
ORTHO-FRAC KIT
K811456 · Orthomedics · Jun 1981
K820469 · WARM & FORM KNEE SUPPORTS
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