Clearance Summary
TORC BODY received FDA 510(k) clearance under submission number K131291, sponsored by Johari Digital Healthcare , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2013-06-14.
- Submission: K131291
- Applicant / Sponsor: Johari Digital Healthcare , Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2013-06-14
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.