Cleared Traditional

K050595 - FT2000 SEQUENCER FOR MUSCLE STIMULATOR

K050595 is an FDA 510(k) clearance for FT2000 SEQUENCER FOR MUSCLE STIMULATOR, manufactured by Midwest Development. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K050595 · Midwest Development · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
76d
Days
Class 2
Risk

K050595 is an FDA 510(k) clearance for the FT2000 SEQUENCER FOR MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Midwest Development (Egale, US). The FDA issued a Cleared decision on May 23, 2005 after a review of 76 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 - K050595

510(k) Number K050595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2005
Decision Date May 23, 2005
Days to Decision 76 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
40d faster than avg
Panel avg: 116d · This submission: 76d
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 490
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K050595.
AXIOM NVP8500
K051135 · Axiom Worldwide, Inc. · Aug 2005
AXIOM EPS8000
K050687 · Axiom Worldwide, Inc. · Jul 2005
IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
K050847 · Theratech, Inc. · Jun 2005
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
K050046 · Compex Technologies, Inc. · Apr 2005
NEUROTECH KNEEHAB
K024258 · Bio-Medical Research, Ltd. · Mar 2005
DIAMOND MEDISTIM
K041390 · Diamond Systems USA, Inc. · Feb 2005
K050595 · FT2000 SEQUENCER FOR MUSCLE STIMULATOR
Download PDF FDA Summary Midwest Development