Biorage Inc · 89-08 · UNITED STATES
For Biorage Inc, import alert is 89-08; country is UNITED STATES; 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 Massager; product code is 89 L - - YG Massager, Therapeutic, Manual; date published is 06/30/2015; address is 9108 Tyler Blvd , Mentor, OH 44060-1881 UNITED STATES, verified against its source on 2026-09-30.
- Firm
- Biorage 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
- UNITED STATES verified
- Address
- 9108 Tyler Blvd , Mentor, OH 44060-1881 UNITED STATES verified
- Date published
- 06/30/2015 verified
- Product code
- 89 L - - YG Massager, Therapeutic, Manual verified
- Product
- Massager verified
- FDA notes
- Rhino Roller; Class II verified
What the source says
Biorage Inc Date Published : 06/30/2015 9108 Tyler Blvd , Mentor, OH 44060-1881 UNITED STATES
— 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
89 L - - YG Massager, Therapeutic, Manual Date Published: 06/30/2015 Desc: Massager Notes: Rhino Roller; Class II
— 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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