Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Measuring Exercise Machine

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Measuring Exercise Machine see related information
Date Initiated by Firm December 03, 2013
Date Posted January 07, 2015
Recall Status1 Terminated 3 on September 29, 2016
Recall Number Z-0936-2015
Recall Event ID 69422
510(K)Number K896553  
Product Classification System, isokinetic testing and evaluation - Product Code IKK
Product Cervical Extension Machine
for Physical Therapy
Code Information Serial Numbers: 02511166, 02511167, 02511171, 02511170.
Recalling Firm/
Manufacturer		 MedX Holdings, Inc.
839 Nw 25th Ave
Ocala FL 34475-5789
For Additional Information Contact Linda Polk
352-351-2005
Manufacturer Reason
for Recall		 Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Medx began contacting its consignees December 30, 2013, to schedule testing on the devices at their facility. The technician has been scheduled to complete required testing of these devices in the field. For questions regarding this recall call 322-351-2005.
Quantity in Commerce 4
Distribution Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
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 = IKK and Original Applicant = MEDX CORP.
-
-