Clearance Summary
AposTherapy System received FDA 510(k) clearance under submission number K182090, sponsored by Apos Medical Assets , 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 2018-11-16.
- Submission: K182090
- Applicant / Sponsor: Apos Medical Assets , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 2018-11-16
Classification & Regulation
This clearance is catalogued under FDA product code QDT and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.