Clearance Summary
GYMFORM DUAL FLEX BELT MODEL WB-162 received FDA 510(k) clearance under submission number K111781, sponsored by Well Brain International , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2012-07-11.
- Submission: K111781
- Applicant / Sponsor: Well Brain International , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2012-07-11
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.