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U.S. Department of Health and Human Services

Class 3 Device Recall Pronto M51 Wheelchair

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  Class 3 Device Recall Pronto M51 Wheelchair see related information
Date Initiated by Firm June 14, 2006
Date Posted August 10, 2006
Recall Status1 Terminated 3 on August 22, 2007
Recall Number Z-1400-06
Recall Event ID 35681
510(K)Number K021680  
Product Classification wheelchair seat - Product Code ITI
Product Pronto M51 Wheelchair, component- seat
Code Information There is no code on the individual seat. Recall covers seats on wheelchairs distributed between 03/14/2006 and 04/07/2006.
Recalling Firm/
Invacare Corporation
1 Invacare Way
PO Box 4028
Elyria OH 44035
For Additional Information Contact Janice Brownlee
Manufacturer Reason
for Recall
Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.
FDA Determined
Cause 2
Action The recalling firm sent a recall letter, dated 06/06 to consignees.
Quantity in Commerce 853 units
Distribution 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 = INVACARE CORP.