SKINREX CO., LTD · 89-08 · KOREA (THE REPUBLIC OF)
For SKINREX CO., LTD, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- 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)
— accessdata.fda.gov, retrieved 2026-09-15
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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html