510(k) K111781
K111781 is an FDA 510(k) premarket notification submitted by Well Brain International , Ltd. for the device "GYMFORM DUAL FLEX BELT MODEL WB-162". The FDA issued a decision of Substantially Equivalent on Jul 11, 2012. The device falls under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning), a Class II device regulated under 21 CFR 890.5850. Well Brain International , Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 11, 2012
- Date Received
- Jun 24, 2011
- 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.