Reference Source

Suzhou Medical Appliance Factory · 89-08 · CHINA

For Suzhou Medical Appliance Factory · 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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 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

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.