# Guangzhou Bio-curve Beauty & Health Equipment · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou Bio-curve Beauty & Health Equipment · 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 Massage Ultrasound Equipment | Therapeutic Skin Ultrasound Devices | Massage Ultrasound Equipment | Massage Ultrasound Equipment | Therapeutic Skin Ultrasound Devices; product code is 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat; date published is 12/21/2010; address is No 2 Workshop Lianyuan Roadsecond Rd , Guangzhouguangzhou, CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Bio-curve Beauty & Health Equipment _(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:** No 2 Workshop Lianyuan Roadsecond Rd , Guangzhouguangzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 12/21/2010 _(verified: appears in the quote below)_
- **Product code:** 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep | 89 E - - GJ Device, Iontophoresis, Other Uses | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat _(verified: each item appears in the quote below)_
- **Product:** Massage Ultrasound Equipment | Therapeutic Skin Ultrasound Devices | Massage Ultrasound Equipment | Massage Ultrasound Equipment | Therapeutic Skin Ultrasound Devices _(verified: each item appears in the quote below)_
- **FDA notes:** Class III ; | Class III ; | Class III | Class III | Class III _(verified: each item appears in the quote below)_

## What the source says

> Guangzhou Bio-curve Beauty & Health Equipment Date Published : 12/21/2010 No 2 Workshop Lianyuan Roadsecond Rd , Guangzhouguangzhou, CHINA 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 06/04/2019 Desc: Massage Ultrasound Equipment Notes: Class III ; 87 L - - PQ Stimulator, ultrasound and muscle, for use other than applying therapeutic deep Date Published: 06/04/2019 Desc: Therapeutic Skin Ultrasound Devices Notes: Class III ; 89 E - - GJ Device, Iontophoresis, Other Uses Date Published: 12/21/2010 Desc: Massage Ultrasound Equipment Notes: Class III 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 12/21/2010 Desc: Massage Ultrasound Equipment Notes: Class III 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 12/21/2010 Desc: Therapeutic Skin Ultrasound Devices Notes: Class III

## 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/).