Soclean, Inc.
United StatesFDA applicant, unverified FDA FEI 3009534409
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 22 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
SoClean 3+ Bacterial Reduction Device Ref DEN210037
Regimes: De Novo Registry: De NovoSoClean 3+ Ref K243815
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009534409
- DUNS number
- 063054904
- Address
- 1 Vose Farm Road, Peterborough, NH, 03458
- [email protected]
- Phone
- 866-501-3705
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 15 Nov 2023 Z-0694-2024 Class II Ongoing New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
Full distribution text
- 15 Nov 2023 Z-0695-2024 Class II Ongoing New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
Full distribution text
- 15 Nov 2023 Z-0694-2024 Class II Ongoing New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.
Frequently asked questions
How many devices does Soclean, Inc. have in the registry?
The registry currently lists 6 devices for Soclean, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Soclean, Inc.'s devices?
Among its 6 most recently registered devices, Soclean, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Soclean, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Soclean, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Soclean, Inc.?
FDA recall records list 2 recalls initiated by Soclean, Inc., the most recent initiated on 15 Nov 2023. 2 of them are 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 Soclean, Inc. in the registry?
The most recently registered devices listed for Soclean, Inc. include SoClean SC1450, SoClean 3+ Bacterial Reduction Device and SoClean 3+.