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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 05, 2005
Date Posted August 17, 2005
Recall Status1 Terminated 3 on October 03, 2006
Recall Number Z-1376-05
Recall Event ID 32657
510(K)Number K924515  
Product Classification Wheelchair, Powered - Product Code ITI
Product UltraLite Vehicles powered by Rascal Motorized Vehicles.
Code Information All units distributed under Model Number UL370.
Recalling Firm/
Manufacturer		 Electric Mobility Corp
599 Mantua Boulevard
One Mobility Plaza
Sewell NJ 08080
For Additional Information Contact Barbara L. Gruman
856-468-1000
Manufacturer Reason
for Recall		 The engager set screw may become loose. This problem may cause the potentiometer to become off-center thus affecting the end users stopping capabilities.
FDA Determined
Cause 2		 Other
Action The firm sent out letters to their customers on 4/20/2005. The firm's sales representatives were also notified on 4/20/2005.
Quantity in Commerce 788 units
Distribution The firm sells the vehicles via direct sales to end customers and also to company owned inventory with sales representatives. The distribution is nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = ELECTRIC MOBILITY CORP.
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