Cleared Traditional

K013081 - MEDSTAR 150

K013081 is an FDA 510(k) clearance for MEDSTAR 150, manufactured by Mednet Services, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K013081 · Mednet Services, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
67d
Days
Class 2
Risk

K013081 is an FDA 510(k) clearance for the MEDSTAR 150. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Mednet Services, Inc. (St. Anthony, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K013081

510(k) Number K013081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2001
Decision Date November 20, 2001
Days to Decision 67 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
49d faster than avg
Panel avg: 116d · This submission: 67d
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 K013081.
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K013771 · Rich-Mar Corp. · Jan 2002
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SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
K011913 · Sun-Rain System Corp. · Oct 2001
EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188
K000741 · 138 Medical Supplies, Inc. · Oct 2001
K013081 · MEDSTAR 150
Download PDF FDA Summary Mednet Services, Inc.