510(k) K230261
K230261 is an FDA 510(k) premarket notification submitted by Creative Fitness Developments S.L. for the device "Gnesis EMS Plus". The FDA issued a decision of Substantially Equivalent on Jun 6, 2023. The device falls under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 2023
- Date Received
- Jan 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered, For Muscle Conditioning
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
- 510(k)
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. 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 and is intended only for muscle conditioning purposes.