Cleared Traditional

VELCRO FINGER/TOE SPLINT

K812654 · Maddak, Inc. · Physical Medicine
Sep 1981
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K812654 is an FDA 510(k) clearance for the VELCRO FINGER/TOE SPLINT, a Splint, Hand, And Components (Class I — General Controls, product code ILH), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 25, 1981, 8 days after receiving the submission on September 17, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K812654 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 1981
Decision Date September 25, 1981
Days to Decision 8 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILH — Splint, Hand, And Components
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475