# Mayu Technology Group Co., Ltd. · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** HONG KONG SAR _(verified: appears in the quote below)_
- **Address:** Unit 2401a , Gala Place; 56 Dundas St. , Mong Kok, Kowloon HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 11/13/2012 _(verified: appears in the quote below)_
- **Product code:** 89 I - - LJ Bath, Hydro-Massage | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** Ion Cleanse Massager | Ion Cleanse Massager _(verified: each item appears in the quote below)_
- **FDA notes:** class II | Class II _(verified: each item appears in the quote below)_

## 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

## 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/).