Healthdirections, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Healthdirections, Inc. makes
Healthdirections, Inc. manufactures the HealthPax HP-1, a Class II medical device designed for [specific function or application—if unspecified, omit or clarify if possible; here, no functional detail is provided, so omit].
The HealthPax HP-1 is regulated under the FDA’s Class II designation and is listed via a 510(k) clearance. The company is based in the United States.
Catalogue
Hp-1 (Healthpax) Ref K883812
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Healthdirections, Inc., the earliest on 2004-04-08 and the most recent on 2007-07-19. By recorded status: 2 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.
2007
- 19 Jul 2007 Z-1242-2007 Unclassified (pre-2012) Terminated Peak voltage test result not in acceptable limits.
2004
- 8 Apr 2004 Z-0019-05 Unclassified (pre-2012) Terminated Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device
Frequently asked questions
How many devices does Healthdirections, Inc. have in the registry?
The registry currently lists 1 device for Healthdirections, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthdirections, Inc.'s devices?
Among its 1 most recently registered device, Healthdirections, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Healthdirections, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Healthdirections, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Healthdirections, Inc.?
FDA recall records list 2 recalls initiated by Healthdirections, Inc., the most recent initiated on 19 Jul 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 Healthdirections, Inc. in the registry?
The most recently registered devices listed for Healthdirections, Inc. include HP-1 (HEALTHPAX).