Cleared Traditional

K871421 - MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT

K871421 is an FDA 510(k) clearance for MODEL HL-100 PORTABLE DC ELECT. THERAPE..., manufactured by Futuremed Div. of Future Impex Corp.. The device is a Class 2 Physical Medicine device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K871421

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 116d · This submission: 288d
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 376
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K871421.
GV 11 (TM), MODEL 9700
K881082 · Medical Devices, Inc. · Mar 1988
SIEMENS NEUROTON 826 AND 827
K875238 · Elmed, 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
RICH-MAR CONDUCTIVE GEL
K872036 · Rich-Mar Corp. · Nov 1987
INTELECT 775
K872655 · Chattanooga Group, Inc. · Nov 1987
K871421 · MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
Download PDF Futuremed Div. of Fut…