Cleared Traditional

TRACTION ACCESSORIES

K844490 · Jerome Medical · Physical Medicine
Feb 1985
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K844490 is an FDA 510(k) clearance for the TRACTION ACCESSORIES, a Accessories, Traction (Class I — General Controls, product code ILZ), submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on February 21, 1985, 93 days after receiving the submission on November 20, 1984. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5925.

Submission Details

510(k) Number K844490 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1984
Decision Date February 21, 1985
Days to Decision 93 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILZ — Accessories, Traction
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5925