Cleared Traditional

E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY (K873604) - FDA 510(k) Clearance

K873604 · Electronic Waveform Laboratory, Inc. · Dental device
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Apr 1988
Decision
221d
Days
-
Risk

K873604 is an FDA 510(k) clearance for the E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY. Classified as Device, Electrical Dental Anesthesia (product code LWM).

Submitted by Electronic Waveform Laboratory, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on April 12, 1988 after a review of 221 days - an extended review cycle.

This device falls under the Dental FDA review panel. 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Electronic Waveform Laboratory, Inc. devices

Submission Details

510(k) Number K873604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1987
Decision Date April 12, 1988
Days to Decision 221 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 127d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWM Device, Electrical Dental Anesthesia
Device Class -