Cleared Traditional

K032833 - MYOSYSTEM WITH CUSTOMIZING

K032833 is an FDA 510(k) clearance for MYOSYSTEM WITH CUSTOMIZING, manufactured by Otto Bock Healthcare LP. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K032833 · Otto Bock Healthcare LP · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
12d
Days
Class 2
Risk

K032833 is an FDA 510(k) clearance for the MYOSYSTEM WITH CUSTOMIZING. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Otto Bock Healthcare LP devices

FDA 510(k) Submission Details - K032833

510(k) Number K032833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2003
Decision Date September 23, 2003
Days to Decision 12 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 149d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Neurology devices follow this clearance model.

Regulatory Peers - GXY Electrode, Cutaneous

All 342
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