Cleared Traditional

K893964 - SPECTRASTIM TM 1000

K893964 is the FDA 510(k) clearance for SPECTRASTIM TM 1000 by Therapeutic Technologies, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K893964 · Therapeutic Technologies, Inc. · Physical Medicine device
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Oct 1989
Decision
126d
Days
Class 2
Risk

K893964 is an FDA 510(k) clearance for the SPECTRASTIM TM 1000. 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 October 6, 1989 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Therapeutic Technologies, Inc. devices

Submission Details

510(k) Number K893964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1989
Decision Date October 06, 1989
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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
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