Maxair
Capr IR Helmet
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (3), Guangdong (2), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| Fofo Medical Co., Ltd. | Xiamen | Fujian | Exporter | 18 |
| Henan Joinkona Medical Products Stock Co., Ltd. | Pingdingshan | Henan | Contract manufacturer | 12 |
| Xianning Full Guard Medical Products Co., Ltd. | Xianning | Hubei | Manufacturer | 10 |
| Hubei Lioncare Protective Products Co., Ltd. | Wuhan | Hubei | Manufacturer | 7 |
Record
| Listed by | Syntech, Int’l Inc., United States |
|---|---|
| FDA product code | FXZ |
| Device type | Helmet, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K040485 |
| Record published | 2026-04-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2085-03-IR | In distribution | |
| 2084-04-PR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmet, Surgical | Stryker GmbH | 16 |
| Flyte | Stryker GmbH | 8 |
| Steri-Shield | Stryker GmbH | 2 |
| Innomed, Inc. | Innomed, Inc. | 1 |
| ViVi® HELMET25 XL HPL | THI Total Healthcare Innovation Gmbh | 1 |
| ViVi® HELMET25 HPL | THI Total Healthcare Innovation Gmbh | 1 |
| ViVi® HELMET25 | THI Total Healthcare Innovation Gmbh | 1 |
| ViVi® HELMET25 XL | THI Total Healthcare Innovation Gmbh | 1 |
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.