Recall Z-0809-2013— CHENICA INC.

Name: FDA recall Z-0809-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-18

Class II · Completed

Class II FDA medical device recall by CHENICA INC., initiated 2013-01-18, terminated 2014-04-15. It names one FDA 510(k) clearance: K111636. Product: Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.. Reason: The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW)..

Recalling firm: CHENICA INC.
Classification: Class II
Status: Completed
Initiated: 2013-01-18
Terminated: 2014-04-15
Firm location: Vassar, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K111636 — REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAMGunnell, Inc.·cleared 2012-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.

Reason for recall

The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).

Data sourced from openFDA. This site is unofficial and independent of the FDA.