Shenzhen Wochuan Electronics Co., Ltd. · 89-08 · CHINA
For Shenzhen Wochuan Electronics Co., Ltd., 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 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 2026-09-30.
- 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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html