Cleared Traditional

SORBOTHANE VISCO INNER SOLE PAD

K831552 · Fred Sammons, Inc. · Physical Medicine
Jun 1983
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K831552 is an FDA 510(k) clearance for the SORBOTHANE VISCO INNER SOLE PAD, a Orthosis, Corrective Shoe (Class I — General Controls, product code KNP), submitted by Fred Sammons, Inc. (Walker, US). The FDA issued a Cleared decision on June 8, 1983, 27 days after receiving the submission on May 12, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K831552 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 08, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code KNP — Orthosis, Corrective Shoe
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475