Shenzhen Pango Electronic Co., Ltd · 89-08 · CHINA
For Shenzhen Pango Electronic 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 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 listed twice: Xikeng Village, Henggang , No. 25 Fenghuang Road; 1st Industry Zone , Shenzhen, Guangdong CHINA and 6/F Dajia Bldg Dongchang Rd Luchu Dist , Shenzhen, CHINA, verified against its source on 2026-09-30.
- Firm
- Shenzhen Pango Electronic 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
- Xikeng Village, Henggang , No. 25 Fenghuang Road; 1st Industry Zone , Shenzhen, Guangdong CHINA verified
- 6/F Dajia Bldg Dongchang Rd Luchu Dist , Shenzhen, CHINA also listed
- Date published
- 02/08/2012 verified
- Product code
- 79 M - - WZ Expander, Breast, External | 89 I - - PF Stimulator, Muscle, Powered | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Breast Enhancer Massager | Breast Enhancer Massager | Breast Enhancer Massager each item verified
- FDA notes
- class II | Class II | class II each item verified
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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
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
— accessdata.fda.gov, retrieved 2026-09-15
Product code
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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html