510(k) K250896

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

December 2, 2025

Date Received

March 25, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Electromagnetic Stimulator For Healthy Muscle Stimulation

Device Class

Class II

Regulation Number

890.5850

Review Panel

PM

Submission Type

A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions.