Guangzhou Bio-curve Beauty & Health Equipment · 89-08 · CHINA
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
- 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
- Massage Ultrasound Equipment | Therapeutic Skin Ultrasound Devices | Massage Ultrasound Equipment | Massage Ultrasound Equipment | Therapeutic Skin Ultrasound Devices 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html