NINGBO BAICHEN MEDICAL DEVICES CO., LTD · 89-08 · CHINA
For NINGBO BAICHEN MEDICAL DEVICES CO., LTD, import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is AEROLUX POWERED WHEELCHAIR; product code is 89 I - - TI Wheelchair, Powered; date published is 04/04/2025; address is Shounan Street Room 903, 666 , Taikang Middle Rd; Yinzhou , Ningbo, Zhejiang CHINA, verified against its source on 2026-09-30.
- Firm
- NINGBO BAICHEN MEDICAL DEVICES CO., LTD verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- Shounan Street Room 903, 666 , Taikang Middle Rd; Yinzhou , Ningbo, Zhejiang CHINA verified
- Date published
- 04/04/2025 verified
- Product code
- 89 I - - TI Wheelchair, Powered verified
- Product
- AEROLUX POWERED WHEELCHAIR verified
What the source says
NINGBO BAICHEN MEDICAL DEVICES CO., LTD Date Published : 04/04/2025 Shounan Street Room 903, 666 , Taikang Middle Rd; Yinzhou , Ningbo, Zhejiang CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
89 I - - TI Wheelchair, Powered Date Published: 04/04/2025 Desc: AEROLUX POWERED WHEELCHAIR
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html