Boucher DeGroot Head Positioning Glasses
Reader, prism, ophthalmic (glasses)
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Fujian (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wenzhou ZHI Cheng Optical Co., Ltd. | Ouhai, Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Dahong Optical (Xiamen) Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
Record
| Listed by | Labtician Ophthalmics, Inc., Canada |
|---|---|
| FDA product code | HJX |
| Device type | Reader, Prism, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5810 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K000544 |
| Record published | 2018-02-26 |
| Record revised | 2021-01-27 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8080 | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K000544 | 2000-03-09 |
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.