# Health Herald · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** Nanchang, Gushu , Xi'Xiang Town, Bao'an District , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 06/05/2013 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II | 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

> 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

## 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/).