Cleared Traditional

K102202 - GS 3000

K102202 is an FDA 510(k) clearance for GS 3000, manufactured by Emsi. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K102202 · Emsi · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
111d
Days
Class 2
Risk

K102202 is an FDA 510(k) clearance for the GS 3000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Emsi (Alexandria, US). The FDA issued a Cleared decision on November 23, 2010 after a review of 111 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K102202

510(k) Number K102202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2010
Decision Date November 23, 2010
Days to Decision 111 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
5d faster than avg
Panel avg: 116d · This submission: 111d
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 368
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K102202.
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