510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103738Substantially Equivalent

H-Wave

Electronic Waveform Laboratory, Inc., Huntington Beach CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103738 is the FDA 510(k) clearance record for H-WAVE, a class II device, cleared for Electronic Waveform Laboratory, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 6 510(k) clearances for Electronic Waveform Laboratory, Inc., from to . As of , FDA records show no recalls naming K103738.

Clearance record

Decision date
Received
(161 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Electronic Waveform Laboratory, Inc. 16168 Beach Blvd., Suite 232, Huntington Beach CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260