Challenge 4010 One Channel Wide Pulse Stimulator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K904360 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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See all devices from Maximum Performance Technologies, Mpts, Inc. →

• What is the primary function of the Challenge 4010?

  The Challenge 4010 is a one channel wide pulse stimulator designed to act as a pulse generator. It is specifically intended to deliver electrical pulse signals for a variety of testing and measurement applications.

• What is the regulatory status of this device?

  The Challenge 4010 has received FDA 510(k) clearance under K-number K904360. This indicates that the device has been found to be substantially equivalent to other legally marketed devices within the Physical Medicine advisory committee category.

• Who is the manufacturer of the Challenge 4010?

  The device is manufactured by Maximum Performance Technologies, Mpts, Inc., which is based in the United States.