Cleared Traditional

K900029 - SPECTRASTIM 2000 MUSCLE STIMULATOR

K900029 is the FDA 510(k) clearance for SPECTRASTIM 2000 MUSCLE STIMULATOR by Therapeutic Technologies, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K900029 · Therapeutic Technologies, Inc. · Physical Medicine device
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Apr 1990
Decision
89d
Days
Class 2
Risk

K900029 is an FDA 510(k) clearance for the SPECTRASTIM 2000 MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Therapeutic Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on April 2, 1990 after a review of 89 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 Therapeutic Technologies, Inc. devices

Submission Details

510(k) Number K900029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1990
Decision Date April 02, 1990
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 128
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K900029.
RICH-MAR IFV 1000
K914539 · Rich-Mar Corp. · Dec 1991
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · Chattanooga Group, Inc. · Oct 1990
RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT
K901779 · Rich-Mar Corp. · Jun 1990
ISOTRON 220
K900823 · Excel Tech. , Ltd. · Mar 1990
INTELECT 775MP POWERED MUSCLE STIMULATOR
K900413 · Chattanooga Group, Inc. · Mar 1990
EMS 8100
K895301 · Henley Intl. · Feb 1990