Reference Source

Mayu Technology Group Co., Ltd. · 89-08 · HONG KONG SAR

For Mayu Technology Group Co., Ltd. · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is Ion Cleanse Massager | Ion Cleanse Massager; product code is 89 I - - LJ Bath, Hydro-Massage | 89 I - - SA Massager, Therapeutic, Electric; date published is 11/13/2012; address is Unit 2401a , Gala Place; 56 Dundas St. , Mong Kok, Kowloon HONG KONG SAR, verified against its source on 2026-09-16.

Firm
Mayu Technology Group 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
HONG KONG SAR verified
Address
Unit 2401a , Gala Place; 56 Dundas St. , Mong Kok, Kowloon HONG KONG SAR verified
Date published
11/13/2012 verified
Product code
89 I - - LJ Bath, Hydro-Massage | 89 I - - SA Massager, Therapeutic, Electric each item verified
Product
Ion Cleanse Massager | Ion Cleanse Massager each item verified
FDA notes
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

Mayu Technology Group Co., Ltd. Date Published : 11/13/2012 Unit 2401a , Gala Place; 56 Dundas St. , Mong Kok, Kowloon HONG KONG SAR 89 I - - LJ Bath, Hydro-Massage Date Published: 11/13/2012 Desc: Ion Cleanse Massager Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/13/2012 Desc: Ion Cleanse Massager Notes: Class II

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

Source

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