Health Herald · 89-08 · CHINA
For Health Herald, 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 Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager; product code is 76 N - - UW Stimulator, Muscle, powered, dental | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis | 85 H - - II Stimulator, Vaginal, Muscle, Powered, for Therapeutic Use | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning; date published is 06/05/2013; address is Nanchang, Gushu , Xi'Xiang Town, Bao'an District , Shenzhen, CHINA, verified against its source on 2026-09-30.
- Firm
- Health Herald 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
- Nanchang, Gushu , Xi'Xiang Town, Bao'an District , Shenzhen, CHINA verified
- Date published
- 06/05/2013 verified
- Product code
- 76 N - - UW Stimulator, Muscle, powered, dental | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis | 85 H - - II Stimulator, Vaginal, Muscle, Powered, for Therapeutic Use | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric | 89 L - - YG Massager, Therapeutic, Manual | 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning each item verified
- Product
- Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager | Electric TENS massager each item verified
- FDA notes
- class II | class II | class II | class II | class II | class II | class II | class II | class II each item verified
What the source says
Health Herald Date Published : 06/05/2013 Nanchang, Gushu , Xi'Xiang Town, Bao'an District , Shenzhen, 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
76 N - - UW Stimulator, Muscle, powered, dental Date Published: 06/05/2013 Desc: Electric TENS massager Notes: class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Electric TENS massager Notes: class II 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 06/05/2013 Desc: Electric TENS massager Notes: class II 84 N - - YN Stimulator, electrical, transcutaneous, for arthritis Date Published: 06/05/2013 Desc: Electric TENS massager Notes: class II 85 H - - II Stimulator, Vaginal, Muscle, Powered, for Therapeutic Use Date Published: 06/05/2013 Desc: Electric TENS massager Notes: class II 89 I - - PF Stimulator, Muscle, Powered Date Published: 06/05/2013 Desc: Electric TENS massager Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 06/05/2013 Desc: Electric TENS massager Notes: class II 89 L - - YG Massager, Therapeutic, Manual Date Published: 06/05/2013 Desc: Electric TENS massager Notes: class II 89 N - - GX Stimulator, Muscle, Powered, for Muscle Conditioning Date Published: 06/05/2013 Desc: Electric TENS massager 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