Clearance Summary
Next Generation iBOT received FDA 510(k) clearance under submission number K172601, sponsored by Deka Research & Development Corp.. 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 2018-03-02.
- Submission: K172601
- Applicant / Sponsor: Deka Research & Development Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3890
- Decision date: 2018-03-02
Classification & Regulation
This clearance is catalogued under FDA product code IMK and 21 CFR 890.3890, within the Physical Medicine review panel as a Class II device.