Cleared Traditional

K080950 - STIWELL MED4

K080950 is an FDA 510(k) clearance for STIWELL MED4, manufactured by Otto Bock, Austria GmbH. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K080950 · Otto Bock, Austria GmbH · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
364d
Days
Class 2
Risk

K080950 is an FDA 510(k) clearance for the STIWELL MED4. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Otto Bock, Austria GmbH (St Paul, US). The FDA issued a Cleared decision on April 2, 2009 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K080950

510(k) Number K080950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2008
Decision Date April 02, 2009
Days to Decision 364 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 116d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 422
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K080950 · STIWELL MED4
Download PDF FDA Summary Otto Bock, Austria Gm…