Therasage Corporation
Country not established
- Devices
- 1
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Therasage Corporation makes
Therasage Corporation manufactures the Therasage Heating Pad, a therapeutic heating device intended for patient use.
The heating pad is classified as a Class II medical device and is listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Therasage Heating Pad Ref K120254
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Therasage Corporation, initiated on 2014-12-23. By recorded status: 3 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 23 Dec 2014 Z-1539-2015 Class II Terminated Product distributed without 510(k) approval
- 23 Dec 2014 Z-1540-2015 Class II Terminated Product distributed without 510(k) approval
- 23 Dec 2014 Z-1541-2015 Class II Terminated Product distributed without 510(k) approval
Frequently asked questions
How many devices does Therasage Corporation have in the registry?
The registry currently lists 1 device for Therasage Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Therasage Corporation's devices?
Among its 1 most recently registered device, Therasage Corporation has devices listed in FDA 510(k) (1 device).
What risk classes do Therasage Corporation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Therasage Corporation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Therasage Corporation?
FDA recall records list 3 recalls initiated by Therasage Corporation, the most recent initiated on 23 Dec 2014. 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 Therasage Corporation in the registry?
The most recently registered devices listed for Therasage Corporation include THERASAGE HEATING PAD.