510(k) K933633
- Device
- Low-vision Reading Aid, Helpmate 2020, Vision-aide, Lv Helpmate
- Applicant
- GRACEFULLY YOURS, INC.
- 510(k) number
- K933633
- Product code
- HJG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-22
- Date received
- 1993-07-27
- Regulation
- 886.5820
- Classification name
- System, Reading, Television, Closed-Circuit
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES F TURNER III
- Address
- 12527 Ulmerton Rd. Largo FL US 34644 34644
FDA Registration Numbers#
- 3003032840
- 1123650
- 3015769026
- 3011898560
- 3009840810
- 3011587055
- 3009330874
- 3003951061
- 3014656175
- 3014656174
- 2936829
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HJG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K915340 | MENTOR HORIZON LOW VISION MAGNIFIER | Mentor O & O, Inc. | 1992-03-30 |
| K920069 | MAGNI-CAM | Innoventions, Inc. | 1992-03-02 |
| K892347 | MAGNILINK SYSTEM 101 | Coburn Optical Ind., Inc. | 1989-05-26 |
| K892348 | MAGNILINK SYSTEM 201 | Coburn Optical Ind., Inc. | 1989-05-26 |
| K892349 | MAGNILINK SYSTEM 209 | Coburn Optical Ind., Inc. | 1989-05-26 |
| K892350 | MAGNILINK SYSTEM 402/5 | Coburn Optical Ind., Inc. | 1989-05-26 |
| K892351 | MAGNILINK SYSTEM 602 | Coburn Optical Ind., Inc. | 1989-05-26 |