510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K050046Substantially Equivalent

Rehabilicare If 3 Wave Interferential Stimulator System, Model 7110S

Compex Technologies, Inc., New Brighton MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050046 is the FDA 510(k) clearance record for REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S, a class II device, cleared for Compex Technologies, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 2 510(k) clearances for Compex Technologies, Inc., from to . As of , FDA records show no recalls naming K050046.

Clearance record

Decision date
Received
(93 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Compex Technologies, Inc. 1811 Old Hwy. 8, New Brighton MN
510(k) summary
Summary PDF
Third party review
Yes

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