510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862121Substantially Equivalent

E.w.l. P-Tens/h-Wave

Electronic Waveform Laboratory, Inc., Huntington Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862121 is the FDA 510(k) clearance record for E.W.L. P-TENS/H-WAVE, a class II device, cleared for Electronic Waveform Laboratory, Inc. on under FDA product code KZM (Device, Muscle Monitoring). FDA records list 6 510(k) clearances for Electronic Waveform Laboratory, Inc., from to . As of , FDA records show no recalls naming K862121.

Clearance record

Decision date
Received
(379 days to decision)
Product code
KZM Device, Muscle Monitoring
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Electronic Waveform Laboratory, Inc. 15683 Chemical Ln., Huntington Beach CA
Third party review
No

Clearances, product code KZM

Trailing 12 months

FDA records hold no clearances under product code KZM in the trailing twelve months.

FDA records show no clearances under product code KZM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260