H-Wave

FDA 510(k) K103738 · Electronic Waveform Laboratory, Inc.

Substantially Equivalent

510(k) numberK103738

Submission

Device name
H-Wave
Applicant
Electronic Waveform Laboratory, Inc.
Huntington Beach, CA, US
Received
December 22, 2010
Decision date
June 1, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IPF – Stimulator, Muscle, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5850
Specialty
Physical Medicine

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K862121E.W.L. P-Tens/H-WaveKZM · Traditional 06/17/1987SE
K813601E.W.L. P-Tens Model(TensGZJ · Traditional 03/19/1982SE

Questions and answers

When was H-Wave cleared by the FDA?

H-Wave (K103738) received a 510(k) decision of Substantially Equivalent on June 1, 2011, 161 days after the submission was received.

What is the product code of K103738?

The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.