Cleared Traditional

K823659 - PELVIC TRACTION BELT

K823659 is an FDA 510(k) clearance for PELVIC TRACTION BELT, manufactured by Warm & Form, Orthopedic Materials. The device is a Class 1 Physical Medicine device with product code ILZ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K823659 · Warm & Form, Orthopedic Materials · Physical Medicine device
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Dec 1982
Decision
24d
Days
Class 1
Risk

K823659 is an FDA 510(k) clearance for the PELVIC TRACTION BELT. Classified as Accessories, Traction (product code ILZ), 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 890.5925 - 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 - K823659

510(k) Number K823659 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.

ILZ Device Classification - Class 1, General Controls

Product Code ILZ Accessories, Traction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5925
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 - ILZ Accessories, Traction

Devices cleared under the same product code (ILZ) and FDA review panel - the closest regulatory comparables to K823659.
SAUNDERS #7080 CERVICAL TRACTION SYS
K831135 · Chattanooga Group, Inc. · Jun 1983
HEAD HALTER
K830245 · Warm & Form, Orthopedic Materials · Mar 1983
PELVIC TRACTION BELT
K823166 · Warm & Form, Orthopedic Materials · Nov 1982
BANDAGE SPREADER BLOCK
K780227 · Biomet, Inc. · Mar 1978
TRACTION BELT, PELVIC
K780234 · Biomet, Inc. · Feb 1978
SPREADER BARS
K780226 · Biomet, Inc. · Feb 1978