Clearance Summary
Indego(R) received FDA 510(k) clearance under submission number K173530, sponsored by Parker-Hannifin Corporation. 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 2018-01-31.
- Submission: K173530
- Applicant / Sponsor: Parker-Hannifin Corporation
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3480
- Decision date: 2018-01-31
Classification & Regulation
This clearance is catalogued under FDA product code PHL and 21 CFR 890.3480, within the Physical Medicine review panel as a Class II device.