Cleared Traditional

K823664 - UNIVERSAL SLING

K823664 is an FDA 510(k) clearance for UNIVERSAL SLING, manufactured by Warm & Form, Orthopedic Materials. The device is a Class 1 Physical Medicine device with product code ILI cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K823664 · Warm & Form, Orthopedic Materials · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
24d
Days
Class 1
Risk

K823664 is an FDA 510(k) clearance for the UNIVERSAL SLING, SLING & SWATHE. Classified as Sling, Arm (product code ILI), 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 890.3640 - 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 - K823664

510(k) Number K823664 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

ILI Device Classification - Class 1, General Controls

Product Code ILI Sling, Arm
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3640
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 - ILI Sling, Arm

All 15
Devices cleared under the same product code (ILI) and FDA review panel - the closest regulatory comparables to K823664.
ARM SLINGS
K831549 · Fred Sammons, Inc. · Jun 1983
VARIOUS ARM SLING
K823808 · Danek Medical, Inc. · Jan 1983
A.C. SPLINT
K823810 · Danek Medical, Inc. · Jan 1983
UNIVERSAL SLING, SLING & SWATHE
K823162 · Warm & Form, Orthopedic Materials · Nov 1982
ORTHOPEDIC SOFT GOODS
K820590 · Abco Dealers, Inc. · Mar 1982
ARM SLING, POUCH TYPE
K812477 · Maddak, Inc. · Sep 1981