FDA-Device2015-06-17Class II
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Advanced Back Technologies, Inc.
Hazard
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Sold states
Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
Affected count
18 units
Manufactured in
89 Cabot Ct Ste F, N/A, Hauppauge, NY, United States
Products
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1718-2015Don't want to check this manually?
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