Cleared Traditional

K823160 - ROTATION BOOT

K823160 is an FDA 510(k) clearance for ROTATION BOOT, manufactured by Warm & Form, Orthopedic Materials. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K823160 · Warm & Form, Orthopedic Materials · Physical Medicine device
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Nov 1982
Decision
16d
Days
Class 1
Risk

K823160 is an FDA 510(k) clearance for the ROTATION BOOT. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Warm & Form, Orthopedic Materials (Walker, US). The FDA issued a Cleared decision on November 10, 1982 after a review of 16 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 - K823160

510(k) Number K823160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date November 10, 1982
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 19
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K823160.
ADJUSTABLE POLYCENTRIC ELBOW HINGE
K831542 · Fred Sammons, Inc. · Jun 1983
VARIOUS SUPPORTS AND SPLINTS
K823812 · Danek Medical, Inc. · Jan 1983
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982
FOREARM & KNEE STRAPS
K811490 · Fred Sammons, Inc. · Jun 1981
LIMB ORTHOSIS
K810443 · Fred Sammons, Inc. · Mar 1981