Suzhou Medical Appliance Factory · 89-08 · CHINA
For Suzhou Medical Appliance Factory, 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 Nerve and Muscle Stimulator | Nerve and Muscle Stimulator | Nerve and Muscle Stimulator; product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric; date published is 03/21/2017; address is Sstt, Site1-Lm, No.18 Huatuo Rd., Sstt, Suzhou New District , No. 18 Huatuo Road; Huqiu District , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-30.
- Firm
- Suzhou Medical Appliance Factory 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
- Sstt, Site1-Lm, No.18 Huatuo Rd., Sstt, Suzhou New District , No. 18 Huatuo Road; Huqiu District , Suzhou, Jiangsu CHINA verified
- Date published
- 03/21/2017 verified
- Product code
- 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Nerve and Muscle Stimulator | Nerve and Muscle Stimulator | Nerve and Muscle Stimulator each item verified
What the source says
Suzhou Medical Appliance Factory Date Published : 03/21/2017 Sstt, Site1-Lm, No.18 Huatuo Rd., Sstt, Suzhou New District , No. 18 Huatuo Road; Huqiu District , Suzhou, Jiangsu 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
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 03/21/2017 Desc: Nerve and Muscle Stimulator 89 I - - PF Stimulator, Muscle, Powered Date Published: 03/21/2017 Desc: Nerve and Muscle Stimulator 89 I - - SA Massager, Therapeutic, Electric Date Published: 03/21/2017 Desc: Nerve and Muscle Stimulator
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html