# Biorage Inc · 89-08 · UNITED STATES — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** UNITED STATES _(verified: appears in the quote below)_
- **Address:** 9108 Tyler Blvd , Mentor, OH 44060-1881 UNITED STATES _(verified: appears in the quote below)_
- **Date published:** 06/30/2015 _(verified: appears in the quote below)_
- **Product code:** 89 L - - YG Massager, Therapeutic, Manual _(verified: appears in the quote below)_
- **Product:** Massager _(verified: appears in the quote below)_
- **FDA notes:** Rhino Roller; Class II _(verified: appears in the quote below)_

## 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

## 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/).