FDA product code HJG: System, Reading, Television, Closed-Circuit
HJG is the FDA product code for system, reading, television, closed-circuit. It is a Class I device, regulated under 21 CFR 886.5820 and reviewed by the Ophthalmic panel. FDA has cleared 8 510(k) submissions under HJG, from 4 different applicants. The average 510(k) review took 85 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | System, Reading, Television, Closed-Circuit |
| Device class | Class I |
| Regulation | 21 CFR 886.5820 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HJG clearance
Top HJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coburn Optical Ind., Inc. | 5 | 1989-05-26 |
| Gracefully Yours, Inc. | 1 | 1994-02-22 |
| Mentor O & O, Inc. | 1 | 1992-03-30 |
| Innoventions, Inc. | 1 | 1992-03-02 |
Most recent HJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933633 | Gracefully Yours, Inc. | LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE | 1994-02-22 | 210 |
| K915340 | Mentor O & O, Inc. | MENTOR HORIZON LOW VISION MAGNIFIER | 1992-03-30 | 158 |
| K920069 | Innoventions, Inc. | MAGNI-CAM | 1992-03-02 | 55 |
| K892348 | Coburn Optical Ind., Inc. | MAGNILINK SYSTEM 201 | 1989-05-26 | 51 |
| K892349 | Coburn Optical Ind., Inc. | MAGNILINK SYSTEM 209 | 1989-05-26 | 51 |
Recalls for HJG devices
openFDA lists no recalls for product code HJG.
Frequently asked questions
What is FDA product code HJG?
HJG is the FDA product code for system, reading, television, closed-circuit. It is a Class I device, regulated under 21 CFR 886.5820 and reviewed by the Ophthalmic panel.
What device class is HJG?
Class I, regulation 21 CFR 886.5820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HJG?
Across 8 cleared submissions the average was 85 days from receipt to decision (median 51).
Which companies have the most HJG clearances?
Coburn Optical Ind., Inc. (5); Gracefully Yours, Inc. (1); Mentor O & O, Inc. (1); Innoventions, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HJG
- Run a recall and safety report across every HJG manufacturer
- Watch product code HJG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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