Clearance Summary
AUTOMATED THERAPY SYSTEM received FDA 510(k) clearance under submission number K891693, sponsored by Harding & Harris, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-08-21.
- Submission: K891693
- Applicant / Sponsor: Harding & Harris, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1989-08-21
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.