Vive
Fall Protection Helmet
10manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (4), Zhejiang (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Dongguan Redthera Technology Co., Ltd. | Dongguan | Guangdong | Repacker / relabeller | 22 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Shenzhen Zhouyang Medical Care Product Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen reanson products Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Guangdong Bole Sports Equipment Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Vive Health LLC, United States |
|---|---|
| FDA product code | NDA |
| Device type | Helmet, Cranial, For Protective Use |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LVA3103GRY | In distribution |
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.