FDA-Device2015-01-14Class II
Lumbar Extension Machine for Physical Therapy
MedX Holdings, Inc.
Hazard
Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Sold states
Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
Affected count
9
Manufactured in
839 Nw 25th Ave, N/A, Ocala, FL, United States
Products
Lumbar Extension Machine for Physical Therapy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0935-2015Don't want to check this manually?
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