Cleared Traditional

K823658 - DELUXE KNEE IMMOBILIZER(UNIVERSAL)

K823658 is an FDA 510(k) clearance for DELUXE KNEE IMMOBILIZER(UNIVERSAL), manufactured by Warm & Form, Orthopedic Materials. The device is a Class 1 Physical Medicine device with product code ITQ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K823658 · Warm & Form, Orthopedic Materials · Physical Medicine device
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Dec 1982
Decision
24d
Days
Class 1
Risk

K823658 is an FDA 510(k) clearance for the DELUXE KNEE IMMOBILIZER(UNIVERSAL). Classified as Joint, Knee, External Brace (product code ITQ), Class I - General Controls.

Submitted by Warm & Form, Orthopedic Materials (Walker, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 24 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.

View all Warm & Form, Orthopedic Materials devices

FDA 510(k) Submission Details - K823658

510(k) Number K823658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date December 30, 1982
Days to Decision 24 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
92d faster than avg
Panel avg: 116d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

ITQ Device Classification - Class 1, General Controls

Product Code ITQ Joint, Knee, External 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 - ITQ Joint, Knee, External Brace

All 7
Devices cleared under the same product code (ITQ) and FDA review panel - the closest regulatory comparables to K823658.
LIMITED MOTION FUNCTIONAL KNEE BRACE
K831044 · Orthopedic Systems, Inc. · Jun 1983
ANATOMIC FRACTURE BRACE
K823397 · Orthopedic Systems, Inc. · Nov 1982
DELUXE KNEE IMMOBILIZER
K823159 · Warm & Form, Orthopedic Materials · Nov 1982
DEMI-WALKER (REGULAR)
K772268 · Med Fusion Systems, Inc. · Dec 1977
SETUP WALKER ADJUSTABLE
K772269 · Med Fusion Systems, Inc. · Dec 1977
SETUP WALKER OVER TOILET CONSTRUC.
K772270 · Med Fusion Systems, Inc. · Dec 1977