Cleared Traditional

K882816 - PULSAR EM

K882816 is an FDA 510(k) clearance for PULSAR EM, manufactured by Apex Medical, Inc.. The device is a Class 2 Physical Medicine device with product code ILX cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K882816 · Apex Medical, Inc. · Physical Medicine device
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Apr 1989
Decision
293d
Days
Class 2
Risk

K882816 is an FDA 510(k) clearance for the PULSAR EM. Classified as Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX), Class II - Special Controls.

Submitted by Apex Medical, Inc. (Martinsville, US). The FDA issued a Cleared decision on April 27, 1989 after a review of 293 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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 Apex Medical, Inc. devices

FDA 510(k) Submission Details - K882816

510(k) Number K882816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1988
Decision Date April 27, 1989
Days to Decision 293 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
178d slower than avg
Panel avg: 115d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILX Device Classification - Class 2, Special Controls

Product Code ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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.