# Shenzhen Wochuan Electronics Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenzhen Wochuan Electronics 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 Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator; product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis | 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief | 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes | 84 O - - CF Stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief; date published is 07/29/2015; address is Fifth Floor, No. 74 Zaoxia Road , Qiao Tou Community Fu Yong Town , Guangdong, CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenzhen Wochuan Electronics Co., Ltd. _(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:** Fifth Floor, No. 74 Zaoxia Road , Qiao Tou Community Fu Yong Town , Guangdong, CHINA _(verified: appears in the quote below)_
- **Date published:** 07/29/2015 _(verified: appears in the quote below)_
- **Product code:** 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use | 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter | 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis | 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief | 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes | 84 O - - CF Stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief _(verified: each item appears in the quote below)_
- **Product:** Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Shenzhen Wochuan Electronics Co., Ltd. Date Published : 07/29/2015 Fifth Floor, No. 74 Zaoxia Road , Qiao Tou Community Fu Yong Town , Guangdong, CHINA 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 07/29/2015 Desc: Transcutaneous Nerve Stimulator Notes: Class II 84 N - - FO Stimulator, Transcutaneous Electrical, for Cosmetic Use Date Published: 07/29/2015 Desc: Transcutaneous Nerve Stimulator Notes: Class II 84 N - - UH Stimulator, Nerve, Transcutaneous, Over-The-Counter Date Published: 07/29/2015 Desc: Transcutaneous Nerve Stimulator Notes: Class II 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis Date Published: 07/29/2015 Desc: Transcutaneous Nerve Stimulator Notes: Class II 84 N - - YW Stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief Date Published: 07/29/2015 Desc: Transcutaneous Nerve Stimulator Notes: Class II 84 N - - YX Stimulator, electrical, transcutaneous, with limted output, for aesthetic purposes Date Published: 07/29/2015 Desc: Transcutaneous Nerve Stimulator Notes: Class II 84 O - - CF Stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief Date Published: 07/29/2015 Desc: Transcutaneous Nerve Stimulator Notes: Class II

## 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/).