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Home Health Devices

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Jintronix Software Gets FDA Clearance As Rehab Therapy for Stroke Patients
05/13/2014
Seattle-based Jintronix has announced that it received 510(k) clearance from the FDA for its rehabilitation software.  Jintronix's system is a set of games and exercises designed for Microsoft's Xbox Kinect system to stimulate recovery in stroke victims.   The Kinect's motion-sensing camera allows players to interact with what they see on the screen, providing  immediate feedback for patients. 

Jintronix sells the Kinect for $250 and charges $50 a month for its software, which lets physical therapists track patient progress, program routines for patients, and adjust the exercises as mobility improves.

According to the company, the FDA clearance is the first time that the Microsoft Kinect has been approved for use directly by patients in a healthcare setting.


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Recall: Playtex® Nurser Deluxe Double Breast Pump Due to Potential for Electric Shock
03/20/2014
Playtex® Manufacturing, Inc. announced a voluntary nationwide recall of certain AC/DC power adapters used with Nurser Deluxe Double Electric Breast Pump because the casing on some adapters may become loose and separate, resulting in potential for electric shock.  No injuries have been reported to date.  Consumers who have purchased an affected product should contact Playtex for a replacement by calling 1-888-207-1429 from 8 a.m. to 6 p.m. ET Monday through Friday or online at www.playtexproducts.com. Consumers should immediately discontinue use of the adapter if it shows signs of separating.

The affected adapters were manufactured from November 2012 through July 2013. The product can be identified by product serial number (P12324-XXXX through P13205-XXXX). Alternatively, the product can be identified by adapter production code (1241 through 1324). The adapters were sold along with the Playtex Nurser Deluxe Double Electric Breast Pump. The adapters were not sold separately.

[1] FDA Recall-- Firm Press Release, "Playtex Announces the Voluntary Nationwide Recall of Certain AC/DC Power Adapters Used with the Playtex® Nurser Deluxe Double Electric Breast Pump Due to Potential for Electric Shock" (March 18, 2014).

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