Vdap
Visibly Digital Acuity Product (VDAP)
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Fabris Lane Eyewear (Wenzhou) Ltd | Wenzhou | Zhejiang | Specification developer | 6 |
| Langfang FAR East Prosperous Optical Instrument Co., Ltd. | Langfang | Hebei | Contract manufacturer | 5 |
Record
| Listed by | Visibly, United States |
|---|---|
| FDA product code | QTO |
| Device type | Digital Visual Acuity Test |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1150 |
| Establishment | Manufacturer |
| 510(k) | K220090 |
| Record published | 2022-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4.2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Manifold Vision Meter | Adaptive Sensory Technology Inc | 4 |
| AMA Optics Digital Vision Test | AMA Optics, Inc. | 1 |
| Oculus Easyfield VR | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies VisiChart® Acuity Chart | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies ACUITYex | The Hilsinger Company Parent, LLC | 1 |
| MyRx Visual Acuity | 6 Over 6 Vision Ltd | 1 |
| M&S Technologies Smart System® 20/20 Tablet | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Smart System® PC-Plus | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Clinical Trial Suite® | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Melbourne Rapid Fields Device In-Clinic | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Smart System® Virtual Reality Headset System | The Hilsinger Company Parent, LLC | 1 |
| M&S Technologies Smart System® Standard | The Hilsinger Company Parent, LLC | 1 |
Showing 12 of 14. All products under Digital Visual Acuity Test
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220090 | 2022-08-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.