Cleared Traditional

K961751 - W.M.E. GPS 1001

K961751 is an FDA 510(k) clearance for W.M.E. GPS 1001, manufactured by Weaver Medical Electronics, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 507-day FDA review.

K961751 · Weaver Medical Electronics, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
507d
Days
Class 2
Risk

K961751 is an FDA 510(k) clearance for the W.M.E. GPS 1001. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Weaver Medical Electronics, Inc. (Longmont, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 507 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Weaver Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K961751

510(k) Number K961751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1996
Decision Date September 25, 1997
Days to Decision 507 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
392d slower than avg
Panel avg: 115d · This submission: 507d
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 258
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K961751.
STELLAR MODEL HS-04
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MSI MAGNA-STYM
K972055 · Microvas Systems, Inc. · Aug 1997
ORTHO DX NEUROMUSCULAR STIMULATOR
K971542 · Rehabilicare, Inc. · Aug 1997