Data / Medical devices / System, Reading, Television, Closed-Circuit
System, Reading, Television, Closed-Circuit (HJG): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make System, Reading, Television, Closed-Circuit (product code HJG, Class 1, 21 CFR 886.5820). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on February 22, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HJG
- Device class
- 1
- Regulation
- 886.5820
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
| Taiwan | 1 |
| India | 1 |
| Ireland | 1 |
Makers of System, Reading, Television, Closed-Circuit
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Acula Technology Corp | Luchu Taoyuan, Taiwan | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enhanced Vision Systems, Inc. | Huntingtn Bch, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freedom Scientific BLV Group, LLC. | Clearwater, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Eyecare Solutions Inc. | Hollister, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rehan Electronics | Carnew Wexford, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoomax Technology Co., Limited | Hangzhou Zhejiang, China | Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 22, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.