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U.S. Department of Health and Human Services

Class 2 Device Recall 3wheeled electric scooter, model HMV 220

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  Class 2 Device Recall 3wheeled electric scooter, model HMV 220 see related information
Date Initiated by Firm November 01, 2005
Date Posted February 16, 2006
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0521-06
Recall Event ID 34405
510(K)Number K033240  
Product Classification Vehicle, Motorized 3-Wheeled - Product Code INI
Product The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. The product is distributed by the Invacare Corporation.
Code Information All serial numbers 04H86001 to 05A468246.
Recalling Firm/
Manufacturer		 Tung Keng Enterprise Co., Ltd.
No.1, Lane 160, Section 2,
Tan-Fu Road
Tai-Tzu Hsiang, Taichung County Taiwan
For Additional Information Contact Janice K. Brownlee
800-333-6900
Manufacturer Reason
for Recall		 The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
FDA Determined
Cause 2		 Other
Action The recalling firm sent field correction instructions to their customers on or about 11/1/05.
Quantity in Commerce 8,213 total devices
Distribution The product was distributed to OHL/Invacare, Rancho Technology Park Bldg. B 8950, Rancho Cucamonga, CA 91730; OHL/Invacare, 1100 Whitaker Road, Plainfield, IN 46168; Invacare Corporation, 39400 Taylor Parkway North Ridgeville, OH 44039; and Invacare, Dallas Texas Distribution Center, 3460 South Watson Rd., Arlington, TX 76014.
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 = INI and Original Applicant = TUNG KENG ENTERPRISE CO., LTD.
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