Ningbo Troika Science & Technology Co.,Ltd. · 89-08 · CHINA
For Ningbo Troika Science & Technology 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 Rocket Pain Relief Pen | Rocket Pain Relief Pen; product code is 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - PF Stimulator, Muscle, Powered; date published is 07/28/2025; address is 11 Gaoya Rd, Jiangshan Town , Yinzhou District , Ningbo, Zhejiang CHINA, verified against its source on 2026-09-30.
- Firm
- Ningbo Troika Science & Technology 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
- 11 Gaoya Rd, Jiangshan Town , Yinzhou District , Ningbo, Zhejiang CHINA verified
- Date published
- 07/28/2025 verified
- Product code
- 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 89 I - - PF Stimulator, Muscle, Powered each item verified
- Product
- Rocket Pain Relief Pen | Rocket Pain Relief Pen each item verified
- FDA notes
- Subject device appears to have design changes and labeling outside the scope of the declared clearance | Subject device appears to have design changes and labeling outside the scope of the declared clearance each item verified
What the source says
Ningbo Troika Science & Technology Co.,Ltd. Date Published : 07/28/2025 11 Gaoya Rd, Jiangshan Town , Yinzhou District , 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, Product and FDA notes
84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 07/28/2025 Desc: Rocket Pain Relief Pen Notes: Subject device appears to have design changes and labeling outside the scope of the declared clearance 89 I - - PF Stimulator, Muscle, Powered Date Published: 07/28/2025 Desc: Rocket Pain Relief Pen Notes: Subject device appears to have design changes and labeling outside the scope of the declared clearance
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html