HJG
8 FDA 510(k) clearances · Product code
51 daysmedian time to decision
210 days90th percentile
8clearances measured
FDA profile
- Official device name
- System, Reading, Television, Closed-Circuit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5820
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE (K933633) | Gracefully Yours, Inc. | 1994-02-22 |
| MENTOR HORIZON LOW VISION MAGNIFIER (K915340) | Mentor O & O, Inc. | 1992-03-30 |
| MAGNI-CAM (K920069) | Innoventions, Inc. | 1992-03-02 |
| MAGNILINK SYSTEM 602 (K892351) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 101 (K892347) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 201 (K892348) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 402/5 (K892350) | Coburn Optical Ind., Inc. | 1989-05-26 |
| MAGNILINK SYSTEM 209 (K892349) | Coburn Optical Ind., Inc. | 1989-05-26 |
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Every clearance here is in the API, with alerts when new ones post.