Challenge 7010 Powered Muscle Stimulator

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

510(k) Number

K902511 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Challenge 6010 Powered Muscle Stimulator

  Class II

  FDA 510(k) K902513 Active Cleared 31 Aug 1990

• Challenge 8000 Powered Muscle Stimulator

  Class II

  FDA 510(k) K902512 Active Cleared 31 Aug 1990

• Challenge 7000 Powered Muscle Stimulator

  Class II

  FDA 510(k) K901770 Active Cleared 3 Jul 1990

• Challenge 20 Powered Muscle Stimulator

  Class II

  FDA 510(k) K901326 Active Cleared 29 May 1990

• Challenge 4010 One Channel Wide Pulse Stimulator

  Class II

  FDA 510(k) K904360 Active Cleared 15 Oct 1991

• Challenge 3000 Neurological Booster

  Class II

  FDA 510(k) K903148 Active Cleared 10 Dec 1991

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

• Is the Challenge 7010 Powered Muscle Stimulator intended for single-use or can it be reused between patients?

  The Challenge 7010 is designed as a reusable medical device. Since it is not classified as sterile, it must be thoroughly cleaned and disinfected between uses following standard infection control protocols to ensure safe and effective operation for multiple patients.

• What types of therapeutic applications is the Challenge 7010 Powered Muscle Stimulator approved for?

  The device is intended for therapeutic use in physical medicine applications, such as rehabilitation, pain management, or muscle re-education. It delivers controlled electrical currents to stimulate muscle contractions via electrodes applied to the target area.

• How is the Challenge 7010 Powered Muscle Stimulator regulated by the FDA, and when was it cleared?

  The Challenge 7010 received FDA clearance under the Traditional 510(k) review pathway, specifically under the product code IPF (Physical Medicine Devices). It was cleared as substantially equivalent on August 31, 1990, with the decision based on the Physical Medicine (PM) advisory committee.

• Does the Challenge 7010 Powered Muscle Stimulator come with any specific storage instructions?

  While the provided data does not explicitly detail storage instructions, as a reusable medical device, it should be stored in a clean, dry environment when not in use. Proper maintenance and care as outlined in the operational manual are essential to ensure longevity and functionality.

• Is the Challenge 7010 Powered Muscle Stimulator safe to use in an MRI environment?

  The available data does not provide any specific information regarding the MRI safety of the Challenge 7010 Powered Muscle Stimulator. Clinicians should consult the manufacturer’s instructions or additional safety documentation before using it in an MRI environment.