# Dectro International, Inc. · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 1000 Du Parc-Technologique Blvd , Quebec, Quebec CANADA _(verified: appears in the quote below)_
- **Date published:** 04/30/2014 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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) _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II | class II | class II | class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).