Clearance Summary
ExoAtlet-II received FDA 510(k) clearance under submission number K201473, sponsored by Exoatlet Asia Co. , 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 2021-07-16.
- Submission: K201473
- Applicant / Sponsor: Exoatlet Asia Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3480
- Decision date: 2021-07-16
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.