Cleared Traditional

K020130 - ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M

K020130 is an FDA 510(k) clearance for ROLOR POWERED MUSCLE STIMULATOR, manufactured by Rolor Electronics Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K020130 · Rolor Electronics Corp. · Physical Medicine device
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Dec 2002
Decision
321d
Days
Class 2
Risk

K020130 is an FDA 510(k) clearance for the ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rolor Electronics Corp. (Hsin-Chu City, TW). The FDA issued a Cleared decision on December 2, 2002 after a review of 321 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.

View all Rolor Electronics Corp. devices

FDA 510(k) Submission Details - K020130

510(k) Number K020130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2002
Decision Date December 02, 2002
Days to Decision 321 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 115d · This submission: 321d
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 239
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K020130.
SYS*STIM 208 AND 208A
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K021588 · Biomedical Life Systems, Inc. · Feb 2003
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K020750 · Everyway Medical Instruments Co.,Ltd · Oct 2002
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K014019 · Bio-Medical Research, Ltd. · Jul 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
K021754 · Apex Medical Corp. · Jun 2002