# Shenzhen Pango Electronic Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenzhen Pango Electronic 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 Breast Enhancer Massager | Breast Enhancer Massager | Breast Enhancer Massager; product code is 79 M - - WZ Expander, Breast, External | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric; date published is 02/08/2012; address is Xikeng Village, Henggang , No. 25 Fenghuang Road; 1st Industry Zone , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenzhen Pango Electronic Co., Ltd _(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:** Xikeng Village, Henggang , No. 25 Fenghuang Road; 1st Industry Zone , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 02/08/2012 _(verified: appears in the quote below)_
- **Product code:** 79 M - - WZ Expander, Breast, External | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Breast Enhancer Massager | Breast Enhancer Massager | Breast Enhancer Massager _(verified: each item appears in the quote below)_
- **FDA notes:** class II | Class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Shenzhen Pango Electronic Co., Ltd Date Published : 02/08/2012 Xikeng Village, Henggang , No. 25 Fenghuang Road; 1st Industry Zone , Shenzhen, Guangdong CHINA 79 M - - WZ Expander, Breast, External Date Published: 02/08/2012 Desc: Breast Enhancer Massager Notes: class II 89 I - - PF Stimulator, Muscle, Powered Date Published: 02/08/2012 Desc: Breast Enhancer Massager Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 02/08/2012 Desc: Breast Enhancer Massager Notes: class II

## The same source also states

> Shenzhen Pango Electronic Co., Ltd Date Published : 02/08/2012 6/F Dajia Bldg Dongchang Rd Luchu Dist , Shenzhen, CHINA 79 M - - WZ Expander, Breast, External Date Published: 02/08/2012 Desc: Breast Enhancer Massager Notes: class II 89 I - - PF Stimulator, Muscle, Powered Date Published: 02/08/2012 Desc: Breast Enhancer Massager Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 02/08/2012 Desc: Breast Enhancer Massager Notes: class II

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## 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/).