Cleared Traditional

K761220 - TECA MODEL SP5/T ELECTRO-THER. STIM.

K761220 is an FDA 510(k) clearance for TECA MODEL SP5/T ELECTRO-THER. STIM., manufactured by Teca, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K761220 · Teca, Inc. · Physical Medicine device
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Dec 1976
Decision
10d
Days
Class 2
Risk

K761220 is an FDA 510(k) clearance for the TECA MODEL SP5/T ELECTRO-THER. STIM.. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Teca, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1976 after a review of 10 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 Teca, Inc. devices

FDA 510(k) Submission Details - K761220

510(k) Number K761220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1976
Decision Date December 17, 1976
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
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.