Dectro International, Inc. · 89-08 · CANADA
For Dectro International, Inc., import alert is 89-08; country is CANADA; 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 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 2026-09-30.
- 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
— 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html