# Innovaciones Disras Sl · 89-08 · SPAIN — FDA import alert red lists: firms subject to detention without physical examination

For Innovaciones Disras Sl · 89-08 · SPAIN, 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 SPAIN; product is OTOSTICK | OTOSTICK; product code is 79 G - - BI Material, External Aesthetic Restoration | 79 H - - XD Clamp; date published is 08/09/2017; address is Pol. Ind. San Isidro - C/L Los Pedregeles N' 66 , Don Benito, Badajoz SPAIN, verified against its source on 2026-09-16.

- **Firm:** Innovaciones Disras Sl _(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:** SPAIN _(verified: appears in the quote below)_
- **Address:** Pol. Ind. San Isidro - C/L Los Pedregeles N' 66 , Don Benito, Badajoz SPAIN _(verified: appears in the quote below)_
- **Date published:** 08/09/2017 _(verified: appears in the quote below)_
- **Product code:** 79 G - - BI Material, External Aesthetic Restoration | 79 H - - XD Clamp _(verified: each item appears in the quote below)_
- **Product:** OTOSTICK | OTOSTICK _(verified: each item appears in the quote below)_
- **FDA notes:** 21 CFR 878.3800 (External aesthetic restoration prosthesis) is the most appropriate device classification for this product. The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears. | 21 CFR 878.3800 (External aesthetic restoration prosthesis) is the most appropriate device classification for this product. The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears. _(verified: each item appears in the quote below)_

## What the source says

> Innovaciones Disras Sl Date Published : 08/09/2017 Pol. Ind. San Isidro - C/L Los Pedregeles N' 66 , Don Benito, Badajoz SPAIN 79 G - - BI Material, External Aesthetic Restoration Date Published: 08/09/2017 Desc: OTOSTICK Notes: 21 CFR 878.3800 (External aesthetic restoration prosthesis) is the most appropriate device classification for this product. The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears. 79 H - - XD Clamp Date Published: 08/09/2017 Desc: OTOSTICK Notes: 21 CFR 878.3800 (External aesthetic restoration prosthesis) is the most appropriate device classification for this product. The labeling for Otostick states that it is an "ear correction device" for which "some adaptation time may be required" and "correct adaptation without any discomfort will be progressively achieved." The labeling also states "corrects excessive prominence of the ears." The intended use appears to cause structure change to the placement of the ears.

## 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/).