Cleared Traditional

K831690 - IPOS ANTI-ADDUCTUS SHOE
(FDA 510(k) Clearance)

K831690 · Ipos Luneburg · Physical Medicine
Jun 1983
Decision
31d
Days
Class 1
Risk

K831690 is an FDA 510(k) clearance for the IPOS ANTI-ADDUCTUS SHOE. This device is classified as a Orthosis, Corrective Shoe (Class I — General Controls, product code KNP).

Submitted by Ipos Luneburg (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983, 31 days after receiving the submission on May 24, 1983.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K831690 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1983
Decision Date June 24, 1983
Days to Decision 31 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