510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K904360Substantially Equivalent

Challenge 4010 One Channel Wide Pulse Stimulator

Maximum Performance Technologies, Mpts, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904360 is the FDA 510(k) clearance record for CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR, a class II device, cleared for Maximum Performance Technologies, Mpts, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 11 510(k) clearances for Maximum Performance Technologies, Mpts, Inc., from to . As of , FDA records show no recalls naming K904360.

Clearance record

Decision date
Received
(386 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Maximum Performance Technologies, Mpts, Inc. C/O Hogan & Hartson, Washington DC
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