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U.S. Department of Health and Human Services

Class 2 Device Recall Golden Technologies Model Number PR515

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 Class 2 Device Recall Golden Technologies Model Number PR515see related information
Date Initiated by FirmJuly 06, 2020
Create DateAugust 17, 2020
Recall Status1 Terminated 3 on June 21, 2021
Recall NumberZ-2817-2020
Recall Event ID 86106
510(K)NumberK880800 
Product Classification Chair, positioning, electric - Product Code INO
ProductGolden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
Code Information Model Number - PR515 Unique Device Identifier (UDI) - B247PR515
FEI Number 2523955
Recalling Firm/
Manufacturer		 Golden Technologies, Inc.
401 Bridge St
Old Forge PA 18518-2323
For Additional Information ContactEd Dziedzic
570-451-7477 Ext. 250
Manufacturer Reason
for Recall		Suspect poor weld on back KD bar.
FDA Determined
Cause 2		Device Design
ActionGolden Tech plans on contacting dealers and internet sellers to inform them of the recall. The firm will provide replacement parts and credit for installation labor compensation.
Quantity in Commerce251
DistributionUS Only
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = INO
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