Cleared Traditional

K973096 - NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM

K973096 is an FDA 510(k) clearance for NEOTONUS MODEL 1000 MUSCLE STIMULATOR S..., manufactured by Neotonus, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K973096 · Neotonus, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
297d
Days
Class 2
Risk

K973096 is an FDA 510(k) clearance for the NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Neotonus, Inc. (North Attleboro, US). The FDA issued a Cleared decision on June 12, 1998 after a review of 297 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neotonus, Inc. devices

FDA 510(k) Submission Details - K973096

510(k) Number K973096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1997
Decision Date June 12, 1998
Days to Decision 297 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 131d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 57
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K973096.
MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc. · Dec 2001
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
K990456 · Hollister, Inc. · Mar 1999
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · Empi · Nov 1998
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K974048 · Hollister, Inc. · Dec 1997
ELPHA 2000 CONTI
K964738 · Dan Med, Inc. · Aug 1997
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
K972054 · Empi · Aug 1997