Clearance Summary
ASLI received FDA 510(k) clearance under submission number K973473, sponsored by Texin Industrial (International) , 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 1997-09-26.
- Submission: K973473
- Applicant / Sponsor: Texin Industrial (International) , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1997-09-26
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.