Guangzhou Bio-curve Beauty & Health Equipment · 89-08 · CHINA
For Guangzhou Bio-curve Beauty & Health Equipment, 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 Therapeutic Skin Ultrasound Devices | Massage Ultrasound Equipment | Massage Ultrasound Equipment | Therapeutic Skin Ultrasound Devices | Massage Ultrasound Equipment; 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 2026-09-30.
- Firm
- Guangzhou Bio-curve Beauty & Health Equipment 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
- No 2 Workshop Lianyuan Roadsecond Rd , Guangzhouguangzhou, CHINA verified
- Date published
- 12/21/2010 verified
- 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 each item verified
- Product
- Therapeutic Skin Ultrasound Devices | Massage Ultrasound Equipment | Massage Ultrasound Equipment | Therapeutic Skin Ultrasound Devices | Massage Ultrasound Equipment each item verified
- FDA notes
- Class III ; | Class III ; | Class III | Class III | Class III each item verified
What the source says
Guangzhou Bio-curve Beauty & Health Equipment Date Published : 12/21/2010 No 2 Workshop Lianyuan Roadsecond Rd , Guangzhouguangzhou, CHINA
— accessdata.fda.gov, retrieved 2026-09-22
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
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 ; 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 ; 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: Therapeutic Skin Ultrasound Devices 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html