510(k) K250759
K250759 is an FDA 510(k) premarket notification submitted by Changsha Anxiang Medical Technology Co., Ltd. for the device "3 in 1 TENS UNIT". The FDA issued a decision of Substantially Equivalent on June 13, 2025. The device falls under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning), a Class II device regulated under 21 CFR 890.5850. Changsha Anxiang Medical Technology Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2025
- Date Received
- March 13, 2025
- 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
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.