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U.S. Department of Health and Human Services

Class 2 Device Recall WalkAide Stimulator System

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  Class 2 Device Recall WalkAide Stimulator System see related information
Date Initiated by Firm August 06, 2008
Date Posted June 03, 2009
Recall Status1 Terminated 3 on July 28, 2009
Recall Number Z-1435-2009
Recall Event ID 52049
510(K)Number K052329  
Product Classification Stimulator, Neuromuscular, External Functional - Product Code GZI
Product WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746.

The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle.
Code Information Serial Numbers: 161024, 161471, 161971, 162121, 162149, 163264, 163424, 163586, 163844, 164343, 164647, 164816, 165459, 166074, 166583, 166725, 167715, 167788, 170292, 170309, 170407, 170425, 170434, 170452, 170523, 170532, 170694, 170701, 170747, 170916, 171040, 171139, 171219, 171362, 171371, 171371, 222093, 222137, 222173, 222235, 222244, 222333, 222379, 222388, 222413, 222431, 222468, 222477, 222502, 222539, 222584, 222593, 222600, 168054, 168072, 168090, 168107, 168116, 168134, 168143, 168189, 168483, 168929, 169357, 169562, 169660, 169893, 170041, 170121, 170238, 220755, 220808, 220960, 221174, 221209, 221263, 221290, 221325, 221389, 221923, 221932, 221941, 221950, 221969, 222048, 222057, 222075, 167813, 167822, 167895, 167902, 167911, 167920, 167939, 167948, 167957, 167966, 167975, 167993, 168009, 168036, 222548, 222575, 167742, 172218, 172343, 203809, 204031, 204273, 204344, 204406, 204415, 204442, 205003, 205236, 208966, 220700, 220728, 169919, 169937, 171433, 222646, 222655, 222673, 222717, 222726, 222735, 222744, 222753, 222799, 222815, 222824, 222922, 222931, 222959, 221996, 222002 and 171442.
Recalling Firm/
Manufacturer		 Innovative Neurotronics, Inc.
3600 North Capital of Texas Hwy
Bldg B Ste 150
Austin TX 78746
Manufacturer Reason
for Recall		 Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Innovative Neurotronics Inc notified the consignee via e-mail on August 6, 2008 of the affected product. The Consignee was asked to place a stop shipment on the WalkAides and to return inventory for replacement. Further questions can be directed to Innovative Neurotronics Inc at 1-512-721-1906.
Quantity in Commerce 137 units
Distribution Nationwide Distribution to the state of GA.
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 = GZI and Original Applicant = INNOVATIVE NEUROTRONICS INC.
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