Reference Source

Shenzhen Pango Electronic Co., Ltd · 89-08 · CHINA

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
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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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 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

accessdata.fda.gov, retrieved 2026-09-15

Source

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