Health Herald · 89-08 · CHINA
For Health Herald · 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html