Shenzhen Wochuan Electronics Co., Ltd. · 89-08 · CHINA
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
- 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
- Fifth Floor, No. 74 Zaoxia Road , Qiao Tou Community Fu Yong Town , Guangdong, CHINA verified
- Date published
- 07/29/2015 verified
- 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 each item verified
- Product
- Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator | Transcutaneous Nerve Stimulator each item verified
- FDA notes
- Class II | Class II | Class II | Class II | Class II | Class II | Class II each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html