Reference Source

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
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

— 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

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