Cleared Traditional

K812984 - SLIMTRONICS 2000

K812984 is an FDA 510(k) clearance for SLIMTRONICS 2000, manufactured by Ems Dist.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K812984 · Ems Dist. · Physical Medicine device
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Jan 1982
Decision
85d
Days
Class 2
Risk

K812984 is an FDA 510(k) clearance for the SLIMTRONICS 2000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Ems Dist. (Mchenry, US). The FDA issued a Cleared decision on January 19, 1982 after a review of 85 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.

View all Ems Dist. devices

FDA 510(k) Submission Details - K812984

510(k) Number K812984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date January 19, 1982
Days to Decision 85 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 116d · This submission: 85d
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 354
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K812984.
HETERODYNAMIC
K821157 · Birtcher Corp. · Jun 1982
MENTOR ACTIVATOR NEUROMUSCULAR STIMU
K820168 · Mentor Corp. · Feb 1982
HIGH VOLTAGE GALVANIC STIMULATOR 550
K813456 · Chattanooga Group, Inc. · Jan 1982
RESPOND II...NEUROMUSCULAR STIMULATOR
K813008 · Medtronic Vascular · Dec 1981
EMPI MODEL 710, NMS
K811395 · Empi · Aug 1981
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K803064 · Zimmer, Inc. · Dec 1980