Dectro International, Inc. · 89-08 · CANADA
For Dectro International, Inc. · 89-08 · CANADA, 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 CANADA; product is Angie Thermocoagulation System (Epilator) | Vitaderm 4000 System (Electric Therapeutic Massager) | Vitalift System (Electric Therapeutic Massager) | Vitalymph Pressotherapy System (Pressure Applying Device) | Vital-Ultra Anti-Cellulite System (Manual Therapeutic Massager); product code is 79 K - - CW Epilator, High Frequency, Needle-Type | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual; date published is 04/30/2014; address is 1000 Du Parc-Technologique Blvd , Quebec, Quebec CANADA, verified against its source on 2026-09-16.
- Firm
- Dectro International, Inc. 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
- CANADA verified
- Address
- 1000 Du Parc-Technologique Blvd , Quebec, Quebec CANADA verified
- Date published
- 04/30/2014 verified
- Product code
- 79 K - - CW Epilator, High Frequency, Needle-Type | 89 I - - SA Massager, Therapeutic, Electric | 89 I - - SA Massager, Therapeutic, Electric | 89 K - - NM Device, Pressure Applying | 89 L - - YG Massager, Therapeutic, Manual each item verified
- Product
- Angie Thermocoagulation System (Epilator) | Vitaderm 4000 System (Electric Therapeutic Massager) | Vitalift System (Electric Therapeutic Massager) | Vitalymph Pressotherapy System (Pressure Applying Device) | Vital-Ultra Anti-Cellulite System (Manual Therapeutic Massager) each item verified
- FDA notes
- class II | class II | class II | class II | class II each item verified
What the source says
Dectro International, Inc. Date Published : 04/30/2014 1000 Du Parc-Technologique Blvd , Quebec, Quebec CANADA 79 K - - CW Epilator, High Frequency, Needle-Type Date Published: 01/13/2015 Desc: Angie Thermocoagulation System (Epilator) Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/13/2015 Desc: Vitaderm 4000 System (Electric Therapeutic Massager) Notes: class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 01/13/2015 Desc: Vitalift System (Electric Therapeutic Massager) Notes: class II 89 K - - NM Device, Pressure Applying Date Published: 01/13/2015 Desc: Vitalymph Pressotherapy System (Pressure Applying Device) Notes: class II 89 L - - YG Massager, Therapeutic, Manual Date Published: 01/13/2015 Desc: Vital-Ultra Anti-Cellulite System (Manual Therapeutic Massager) Notes: class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html