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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 116d · 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 538
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K020130.
MEDS-3 NEUROMUSCULAR STIMULATOR
K023446 · Medical Equipment Device Specialists · Jan 2003
PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000
K024036 · Johari Digital Healthcare , Ltd. · Dec 2002
VITAL STIM
K023347 · Chattanooga Group · Dec 2002
DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
K020750 · Everyway Medical Instruments Co.,Ltd · Oct 2002
EMS 400
K022493 · Body Clock Health Care, Ltd. · Oct 2002
NESS SYSTEM
K022776 · Ness-Neuromuscular Electrical Stimulation Systems · Sep 2002
K020130 · ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
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