Cleared Traditional

E.W.L. P-TENS/H-WAVE (K862121) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.