Cleared Traditional

SORBOTHANE

K810228 · Hamilton Kent · Physical Medicine
Feb 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K810228 is an FDA 510(k) clearance for the SORBOTHANE, a Orthosis, Corrective Shoe (Class I — General Controls, product code KNP), submitted by Hamilton Kent (Mchenry, US). The FDA issued a Cleared decision on February 10, 1981, 14 days after receiving the submission on January 27, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K810228 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1981
Decision Date February 10, 1981
Days to Decision 14 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