Cleared Traditional

K972997 - AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION

K972997 is an FDA 510(k) clearance for AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL..., manufactured by Dan Med, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972997 · Dan Med, Inc. · Physical Medicine device
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Nov 1997
Decision
90d
Days
Class 2
Risk

K972997 is an FDA 510(k) clearance for the AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Dan Med, Inc. (Denver, US). The FDA issued a Cleared decision on November 10, 1997 after a review of 90 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 Dan Med, Inc. devices

FDA 510(k) Submission Details - K972997

510(k) Number K972997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date November 10, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 279
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K972997.
ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
K980346 · Universal Technology Systems, Inc. · Apr 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448 · Radionics, Inc. · Apr 1998
STELLAR MODEL HS-04
K973223 · Stellar Medical Corp. · Feb 1998
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
K964434 · Skylark Device Co., Ltd. · Oct 1997
W.M.E. GPS 1001
K961751 · Weaver Medical Electronics, Inc. · Sep 1997
IMPULSE HVG
K970847 · Armstrong Industries, Inc. · Sep 1997