Recall Z-1131-2014— AlterG, Incorporated
Class II · Terminated
Class II FDA medical device recall by AlterG, Incorporated, initiated 2014-01-28, terminated 2014-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.. Reason: Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient..
- Recalling firm
- AlterG, Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-28
- Terminated
- 2014-05-13
- Firm location
- Fremont, CA, United States
Product description
Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
Reason for recall
Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.