SKINREX CO., LTD · 89-08 · KOREA (THE REPUBLIC OF)
For SKINREX CO., LTD · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Cavi-Lipo Massager | Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT | Cavi-Lipo Massager | Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT; product code is 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 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 11/25/2013; address is 507HO JOONGANDINDUSPIA 2 , 144-5 SANGDAEWON-DONG, JUNGWON-GU , SEONGNAM-SI, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- SKINREX 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 507HO JOONGANDINDUSPIA 2 , 144-5 SANGDAEWON-DONG, JUNGWON-GU , SEONGNAM-SI, KOREA (THE REPUBLIC OF) verified
- Date published
- 11/25/2013 verified
- Product code
- 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 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
- Cavi-Lipo Massager | Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT | Cavi-Lipo Massager | Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT each item verified
- FDA notes
- Class III | Class III each item verified
What the source says
SKINREX CO., LTD Date Published : 11/25/2013 507HO JOONGANDINDUSPIA 2 , 144-5 SANGDAEWON-DONG, JUNGWON-GU , SEONGNAM-SI, KOREA (THE REPUBLIC OF) 89 I - - SA Massager, Therapeutic, Electric Date Published: 11/25/2013 Desc: Cavi-Lipo Massager Notes: Class III 89 I - - SA Massager, Therapeutic, Electric Date Published: 04/27/2016 Desc: Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 11/25/2013 Desc: Cavi-Lipo Massager Notes: Class III 89 L - - XF Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat Date Published: 04/27/2016 Desc: Zero-Body; Cavi-Lipo Deluxe; Cavi-Lipo GT
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html