Scottcare
United Statesfrom the FDA registration address FDA FEI 1527715
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Scottcare makes
Scottcare manufactures the TELEREHAB 2004, a telehealth-enabled rehabilitation device designed for remote patient monitoring and therapy management.
The device is classified as Class II under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Telerehab System For Cardiac Rehabilitation Ref K895719
Regimes: 510(k) Registry: 510(k)Telerehad 2004 Ref K050778
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1527715
- Address
- 4791 WEST 150TH ST., CLEVELAND, OH, 44135
FDA recalls
FDA recall records list 2 recalls initiated by Scottcare, the earliest on 2012-01-19 and the most recent on 2016-02-25. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 25 Feb 2016 Z-1315-2016 Class II Terminated The firm received a complaint of the battery exploding while recharging.
Full distribution text
- 25 Feb 2016 Z-1315-2016 Class II Terminated The firm received a complaint of the battery exploding while recharging.
2012
- 19 Jan 2012 Z-1400-2012 Not yet classified Terminated Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning.
Full distribution text
- 19 Jan 2012 Z-1400-2012 Not yet classified Terminated Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning.
Frequently asked questions
How many devices does Scottcare have in the registry?
The registry currently lists 2 devices for Scottcare. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scottcare's devices?
Among its 2 most recently registered devices, Scottcare has devices listed in FDA 510(k) (2 devices).
What risk classes do Scottcare's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Scottcare's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Scottcare?
FDA recall records list 2 recalls initiated by Scottcare, the most recent initiated on 25 Feb 2016. 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 Scottcare in the registry?
The most recently registered devices listed for Scottcare include TELEREHAB SYSTEM FOR CARDIAC REHABILITATION and TELEREHAD 2004.