Data / Medical devices / Aid, Vision, Electronic, Battery-Powered
Aid, Vision, Electronic, Battery-Powered (HPG): 10 FDA-registered makers in 7 countries
10 establishments in 7 countries are registered with the FDA to make Aid, Vision, Electronic, Battery-Powered (product code HPG, Class 1, 21 CFR 886.5900). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on May 14, 1991, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HPG
- Device class
- 1
- Regulation
- 886.5900
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Ireland | 2 |
| Canada | 1 |
| India | 1 |
| Denmark | 1 |
| Israel | 1 |
| China | 1 |
Makers of Aid, Vision, Electronic, Battery-Powered
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 |
|---|---|---|---|---|---|---|---|---|
| Agiga, Inc. | Milpitas, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ambutech Inc. | WINNIPEG Manitoba, Canada | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Medical Denmark ApS | TAASTRUP Hovedstaden, Denmark | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Sensory Ireland Ltd | Gort Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ocutech, Inc. | Chapel Hill, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ocutrx Technologies | Tulsa, OK, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orcam Technologies Ltd | Jerusalem, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rehan Electronics | Carnew Wexford, Ireland | 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 May 14, 1991. 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.