Cleared Traditional

K052771 - SENSOR WALK

K052771 is an FDA 510(k) clearance for SENSOR WALK, manufactured by Otto Bock Healthcare LP. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K052771 · Otto Bock Healthcare LP · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
215d
Days
Class 1
Risk

K052771 is an FDA 510(k) clearance for the SENSOR WALK. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on May 3, 2006 after a review of 215 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Otto Bock Healthcare LP devices

FDA 510(k) Submission Details - K052771

510(k) Number K052771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 115d · This submission: 215d
Pathway characteristics
Predicate-based equivalence.

IQI Device Classification - Class 1, General Controls

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IQI Orthosis, Limb Brace

All 20
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K052771.
ADJUSTABLE POLYCENTRIC ELBOW HINGE
K831542 · Fred Sammons, Inc. · Jun 1983
VARIOUS SUPPORTS AND SPLINTS
K823812 · Danek Medical, Inc. · Jan 1983
ROTATION BOOT
K823160 · Warm & Form, Orthopedic Materials · Nov 1982
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982
FOREARM & KNEE STRAPS
K811490 · Fred Sammons, Inc. · Jun 1981