FDA Registration
Inactive
🇨🇳 China
ZygenAir/OxyLume/OxtraCare
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HANGZHOU YOUHONGYUANZHI TECHNOLOGY CO.,LTD
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 507, 5th Floor, Tianren Building, No. 188 Liyi Road, Ningwei Subdistrict, Xiaoshan District, Hangzhou
- City
- Zhejiang Province
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240329
Owner / Operator
- Firm Name
- Hangzhou Youhongyuanzhi Technology Co.,Ltd
- Operator Number
- 10093768
- Address
- Room 507, 5th Floor, Tianren Building, No. 188 Liyi Road, Ningwei Subdistrict, Xiaoshan District, Hangzhou
- City
- Zhejiang Province
- State
- CN-ZJ
- Postal Code
- 311200
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Dr
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2025-07-07 |
Proprietary Names
ZygenAir/OxyLume/OxtraCare
Establishment Types
Export Device to the United States But Perform No Other Operation on Device