Cleared Traditional

K862121 - E.W.L. P-TENS/H-WAVE

K862121 is an FDA 510(k) clearance for E.W.L. P-TENS/H-WAVE, manufactured by Electronic Waveform Laboratory, Inc.. The device is a Class 2 Dental device with product code KZM cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K862121 · Electronic Waveform Laboratory, Inc. · Dental device
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Jun 1987
Decision
379d
Days
Class 2
Risk

K862121 is an FDA 510(k) clearance for the E.W.L. P-TENS/H-WAVE. Classified as Device, Muscle Monitoring (product code KZM), Class II - Special Controls.

Submitted by Electronic Waveform Laboratory, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on June 17, 1987 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.1375 - the FDA dental device regulatory 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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K862121

510(k) Number K862121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date June 17, 1987
Days to Decision 379 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 127d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZM Device Classification - Class 2, Special Controls

Product Code KZM Device, Muscle Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 Dental devices follow this clearance model.