FDA-Device2014-03-12Class II

Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.

AlterG, Incorporated
Hazard

Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.

Sold states
Worldwide Distribution:US (nationwide) and to countries: Australia, Netherlands, United Kingdom, Spain, Germany, France, Denmark, Switzerland, Poland, Slovak Republic, Austria, and United Arab Emirates.
Affected count
2221 devices
Manufactured in
48438 Milmont Dr, Fremont, CA, United States
Products
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1131-2014

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