Homedics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Homedics, Inc. makes
Homedics, Inc. manufactures paraffin bath devices, including the PARASPA PARAFFIN BATH, PARASPAP MINI, and PARASPA ULTRA, designed for therapeutic heat application. The company also produces the SONICWAVE SONIC PLAQUE REMOVER, a device intended for plaque removal in home settings.
These products are regulated under the FDA’s 510(k) pathway, with some classified as Class I and others as Class II. The devices are listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Sonicwave Sonic Plaque Remover Ref K012914
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by Homedics, Inc., initiated on 2007-02-09. By recorded status: 5 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.
2007
- 9 Feb 2007 Z-0622-2007 Unclassified (pre-2012) Terminated Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
- 9 Feb 2007 Z-0623-2007 Unclassified (pre-2012) Terminated Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
- 9 Feb 2007 Z-0624-2007 Unclassified (pre-2012) Terminated Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
- 9 Feb 2007 Z-0625-2007 Unclassified (pre-2012) Terminated Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
- 9 Feb 2007 Z-0626-2007 Unclassified (pre-2012) Terminated Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Frequently asked questions
How many devices does Homedics, Inc. have in the registry?
The registry currently lists 2 devices for Homedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Homedics, Inc.'s devices?
Among its 2 most recently registered devices, Homedics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Homedics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Homedics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Homedics, Inc.?
FDA recall records list 5 recalls initiated by Homedics, Inc., the most recent initiated on 9 Feb 2007. 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 Homedics, Inc. in the registry?
The most recently registered devices listed for Homedics, Inc. include PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA and SONICWAVE SONIC PLAQUE REMOVER.