# Suzhou Medical Appliance Factory · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Sstt, Site1-Lm, No.18 Huatuo Rd., Sstt, Suzhou New District , No. 18 Huatuo Road; Huqiu District , Suzhou, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 03/21/2017 _(verified: appears in the quote below)_
- **Product code:** 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Nerve and Muscle Stimulator | Nerve and Muscle Stimulator | Nerve and Muscle Stimulator _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).