510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K003631Substantially Equivalent

Smartwave If 2000

Newwave Medical, LLC, Plano TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003631 is the FDA 510(k) clearance record for SMARTWAVE IF 2000, a class II device, cleared for Newwave Medical, LLC on under FDA product code LIH (Interferential Current Therapy). FDA records list 3 510(k) clearances for Newwave Medical, LLC, from to . As of , FDA records show no recalls naming K003631.

Clearance record

Decision date
Received
(259 days to decision)
Product code
LIH Interferential Current Therapy
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Newwave Medical, LLC 620 Haggard St., Plano TX
510(k) summary
Summary
Third party review
No

Clearances, product code LIH

Trailing 12 months

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

FDA records show no clearances under product code LIH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIH, 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