510(k) Report

510(k) · Cleared

Cleared

E.W.L. P-Tens/H-Wave

K862121510(k) TraditionalCleared Jun 17, 1987379-day reviewClass II21 CFR 890.1375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Electronic Waveform Laboratory, Inc. · KZM Device, Muscle Monitoring

Cleared on Jun 17, 1987 after a 379-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 17, 1987
Review
379 days
Class
Class II
Product code
KZM
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K862121Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KZM devices

KZM Device, Muscle Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZM

1in 2016

2009: 12012: 12013: 12016: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZM

Too few KZM 510(k)s in any year since 2007 to give a median.

Recalls per year · KZM

No recall names KZM since 2007.

Adverse event reports per year · KZM

No MAUDE report names KZM since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20121—00
20131—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Electronic Waveform Laboratory, Inc.

6 FDA decisions under this applicant name. See the company

  • K103738H-WAVEElectronic Waveform Laboratory, Inc. · 2011
  • K081998H-Wave SportElectronic Waveform Laboratory, Inc. · 2009
  • K915230H Wave Muscle StimulatorElectronic Waveform Laboratory, Inc. · 1992
  • K873604E.W.L. P-Tens/H-Wave for General DentistryElectronic Waveform Laboratory, Inc. · 1988
  • K813601E.W.L. P-Tens Model (TensElectronic Waveform Laboratory, Inc. · 1982

Recent decisions in KZM

The KZM category page

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  • K130158M-SCANBio-Research Associates, Inc. · 2013
  • K113677Grindcare MeasureMedotech A/S · 2012
  • K082927Bioemg IiiBio-Research Associates, Inc. · 2009
  • K043373Dolotens Dental TM 1Neuromuscular Technologies, Inc. · 2005

https://510kreport.com/device/K862121 · printed Nov 5, 2026

Cite this page

510(k) Report. “K862121: E.W.L. P-Tens/H-Wave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K862121

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026