Cleared Traditional

K872574 - TENSAGAIN

K872574 is an FDA 510(k) clearance for TENSAGAIN, manufactured by Ferris Mfg. Corp.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K872574 · Ferris Mfg. Corp. · Neurology device
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Jul 1987
Decision
23d
Days
Class 2
Risk

K872574 is an FDA 510(k) clearance for the TENSAGAIN. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on July 23, 1987 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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 Ferris Mfg. Corp. devices

FDA 510(k) Submission Details - K872574

510(k) Number K872574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1987
Decision Date July 23, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 148d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Neurology devices follow this clearance model.

Regulatory Peers - GXY Electrode, Cutaneous

All 307
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K872574.
TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING
K880649 · Labeltape Meditect, Inc. · Mar 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K875284 · Medtronic Vascular · Jan 1988
LECTEC STIMULATING ELECTRODE
K872250 · Lectec Corp. · Aug 1987
CARBON ELECTRODE
K872044 · Futuremed Div. of Future Impex Corp. · Jul 1987
DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS
K871026 · Labeltape Meditect, Inc. · Apr 1987
TENZCARE(TM) SNAP ELECTRODE 6867
K864973 · 3M Company · Jan 1987