Clearance Summary
LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE received FDA 510(k) clearance under submission number K933633, sponsored by Gracefully Yours, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-02-22.
- Submission: K933633
- Applicant / Sponsor: Gracefully Yours, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5820
- Decision date: 1994-02-22
Classification & Regulation
This clearance is catalogued under FDA product code HJG and 21 CFR 886.5820, within the Ophthalmic review panel as a Class I device.