Cleared Traditional

K791048 - STIMTECH NEUROMUSCULAR STIMULATOR, C 600

K791048 is an FDA 510(k) clearance for STIMTECH NEUROMUSCULAR STIMULATOR, manufactured by Stimulation Technology, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K791048 · Stimulation Technology, Inc. · Physical Medicine device
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Jul 1979
Decision
27d
Days
Class 2
Risk

K791048 is an FDA 510(k) clearance for the STIMTECH NEUROMUSCULAR STIMULATOR, C 600. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Stimulation Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 3, 1979 after a review of 27 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 - K791048

510(k) Number K791048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1979
Decision Date July 03, 1979
Days to Decision 27 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 116d · This submission: 27d
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 543
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K791048.
INTELECT
K801790 · Chattanooga Group, Inc. · Aug 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · Medtronic Vascular · May 1980
PORTABLE PULSE GALVANIC STIMULATOR
K791087 · Staodynamics, Inc. · Oct 1979
EGS MODEL 300
K790847 · Alfred V. Greco · May 1979
SLENDERTONE
K790120 · Bloomex International, Inc. · May 1979
HVG-100
K790033 · Elmed, Inc. · Feb 1979
K791048 · STIMTECH NEUROMUSCULAR STIMULATOR, C 600
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