Cleared Traditional

K884396 - MODIFIED THER-A-PULSE UNIT

K884396 is an FDA 510(k) clearance for MODIFIED THER-A-PULSE UNIT, manufactured by Westec Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K884396 · Westec Corp. · Physical Medicine device
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May 1989
Decision
211d
Days
Class 2
Risk

K884396 is an FDA 510(k) clearance for the MODIFIED THER-A-PULSE UNIT. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Westec Corp. (Falls Church, US). The FDA issued a Cleared decision on May 18, 1989 after a review of 211 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 Westec Corp. devices

FDA 510(k) Submission Details - K884396

510(k) Number K884396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1988
Decision Date May 18, 1989
Days to Decision 211 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
96d slower than avg
Panel avg: 115d · This submission: 211d
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 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K884396.
SYS*STIM 207A
K893879 · Mettler Electronics Corp. · Dec 1989
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
K893994 · Rich-Mar Corp. · Dec 1989
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
K884651 · Biomedical Life Systems, Inc. · Nov 1989
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA
K890147 · Rich-Mar Corp. · Mar 1989
ENDOMED CV405
K880699 · Henley Intl. · May 1988
RICH-MAR G1000 EMS
K880948 · Rich-Mar Corp. · Apr 1988