Biorage Inc · 89-08 · UNITED STATES
For Biorage Inc · 89-08 · UNITED STATES, 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 UNITED STATES; 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 2026-09-16.
- 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 89 L - - YG Massager, Therapeutic, Manual Date Published: 06/30/2015 Desc: Massager Notes: Rhino Roller; Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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