Cleared Traditional

K881024 - ARCHGAUGE(TM)

K881024 is the FDA 510(k) clearance for ARCHGAUGE(TM) by Archxerciser Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K881024 · Archxerciser Corp. · Physical Medicine device
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Apr 1988
Decision
29d
Days
Class 2
Risk

K881024 is an FDA 510(k) clearance for the ARCHGAUGE(TM). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Archxerciser Corp. (St. Louis, US). The FDA issued a Cleared decision on April 8, 1988 after a review of 29 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 Archxerciser Corp. devices

Submission Details

510(k) Number K881024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date April 08, 1988
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 143
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K881024.
ENDOMED CV405
K880699 · Henley Intl. · May 1988
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INTELECT MODEL 120
K880235 · Chattanooga Group, Inc. · Apr 1988
GV 11 (TM), MODEL 9700
K881082 · Medical Devices, Inc. · Mar 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234 · Chattanooga Group, Inc. · Feb 1988
RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR
K874736 · Rich-Mar Corp. · Jan 1988