Cleared Traditional

WRIST SUPPORT

K823601 · Fred Sammons, Inc. · Physical Medicine
Dec 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K823601 is an FDA 510(k) clearance for the WRIST SUPPORT, a Splint, Hand, And Components (Class I — General Controls, product code ILH), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982, 16 days after receiving the submission on December 6, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K823601 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1982
Decision Date December 22, 1982
Days to Decision 16 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