Ningbo Troika Science & Technology Co.,Ltd. · 89-08 · CHINA
For Ningbo Troika Science & Technology Co.,Ltd. · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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