Innovaciones Disras Sl · 89-08 · SPAIN
For Innovaciones Disras Sl, import alert is 89-08; country is SPAIN; 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 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 2026-09-30.
- Firm
- Innovaciones Disras Sl 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
- SPAIN verified
- Address
- Pol. Ind. San Isidro - C/L Los Pedregeles N' 66 , Don Benito, Badajoz SPAIN verified
- Date published
- 08/09/2017 verified
- Product code
- 79 G - - BI Material, External Aesthetic Restoration | 79 H - - XD Clamp each item verified
- Product
- OTOSTICK | OTOSTICK each item verified
- 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. each item verified
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
— 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 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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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