Cleared Traditional

K871421 - MODEL HL-100 PORTABLE DC ELECT. THERAPE...

K871421 is the FDA 510(k) clearance for MODEL HL-100 PORTABLE DC ELECT. THERAPE... by Futuremed Div. of Future Impex Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K871421 · Futuremed Div. of Future Impex Corp. · Physical Medicine device
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Jan 1988
Decision
288d
Days
Class 2
Risk

K871421 is an FDA 510(k) clearance for the MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Futuremed Div. of Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 288 days - an extended review 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: 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 Futuremed Div. of Future Impex Corp. devices

Submission Details

510(k) Number K871421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1987
Decision Date January 22, 1988
Days to Decision 288 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
173d slower than avg
Panel avg: 115d · This submission: 288d
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 85
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K871421.
INTELECT 775MP POWERED MUSCLE STIMULATOR
K900413 · Chattanooga Group, Inc. · Mar 1990
INTELECT MODEL 120
K880235 · Chattanooga Group, Inc. · Apr 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234 · Chattanooga Group, Inc. · Feb 1988
INTELECT 775
K872655 · Chattanooga Group, Inc. · Nov 1987
INTELECT MODEL 575
K872654 · Chattanooga Group, Inc. · Sep 1987
INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986