Data / Medical devices / United States / Rebiscan, Inc.
Rebiscan, Inc.: FDA-registered device maker in Boston, MA, United States, 1 510(k) clearance
Rebiscan, Inc. is registered with the FDA (registration 3014522421) in Boston, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 8, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014522421
- Address
- 100 Cambridge Street 14th Floor, Boston, MA, United States, 02114
- Owner or operator
- Rebiscan, Inc. (10057507)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 17, 2018
- Registered through
- 2026
- Brand names listed
- PVS, blinq.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Strabismus Detection Device | PMW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 8, 2016 | DEN130051 | PEDIATRIC VISION SCANNER | PMW | Unknown | Rebiscan, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 3, 2022 | 90968 | Class II | Ongoing | Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830 | Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the charge, could vent and possibly catch fire | accessdata.fda.gov |
Updated November 1, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.