Cleared Traditional

SENSOR WALK

K052771 · Otto Bock Healthcare LP · Physical Medicine
May 2006
Decision
215d
Days
Class 1
Risk

About This 510(k) Submission

K052771 is an FDA 510(k) clearance for the SENSOR WALK, a Orthosis, Limb Brace (Class I — General Controls, product code IQI), submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on May 3, 2006, 215 days after receiving the submission on September 30, 2005. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K052771 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2005
Decision Date May 03, 2006
Days to Decision 215 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IQI — Orthosis, Limb Brace
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475