Rebiscan, Inc.
United Statesfrom the FDA registration address FDA FEI 3014522421
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
- Registry: GUDID
Pediatric Vision Scanner Ref DEN130051
Regimes: De Novo Registry: De Novo
Company details
- FDA FEI number
- 3014522421
- DUNS number
- 831265967
- Address
- 100 Cambridge Street, Boston, MA, 02114
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 3 Oct 2022 Z-0168-2023 Class II Ongoing 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
Frequently asked questions
How many devices does Rebiscan, Inc. have in the registry?
The registry currently lists 2 devices for Rebiscan, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rebiscan, Inc.'s devices?
Among its 2 most recently registered devices, Rebiscan, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Rebiscan, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Rebiscan, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rebiscan, Inc.?
FDA recall records list 1 recall initiated by Rebiscan, Inc., the most recent initiated on 3 Oct 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Rebiscan, Inc. in the registry?
The most recently registered devices listed for Rebiscan, Inc. include Blinq 1 and PEDIATRIC VISION SCANNER.