Cleared Traditional

K830245 - HEAD HALTER (FDA 510(k) Clearance)

Class I Physical Medicine device.

K830245 · Warm & Form, Orthopedic Materials · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
43d
Days
Class 1
Risk

K830245 is an FDA 510(k) clearance for the HEAD HALTER. Classified as Accessories, Traction (product code ILZ), Class I - General Controls.

Submitted by Warm & Form, Orthopedic Materials (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 43 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

Submission Details

510(k) Number K830245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date March 09, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.