US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure
FDA Recall Z-1819-2012 · Posted 2012-06-18
Recalling FirmNon-Invasive Monitoring Systems, Inc.
Recall StatusTerminated
Product CodeIRO
Date Initiated2012-05-07
Date Terminated2012-07-16
Product QuantityUS-001 Rev A brochure: 3665
Reason for Recall
Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Firm Action
NiMS sent an Urgent Promotional Material Recall letter dated May 29, 2012, to all affected customers. NIMS contacted the 18 facilities by phone starting on May 29, 2012 and sent the 73 end users letters dated May 29, 2012. NiMS instructed customers to immediately examine their inventory and quarantine any of the US-001 or USA-002 brochures. If customers further distributed brochures customers were instructed to notify their customers at once by including a copy of the recall notification letter. Customers were requested to destroy all Exer-Rest promotional materials.
For any questions customers were instructed to call 305-575-4204.
For questions regarding this recall call 305-575-4201.
Root Cause
Labeling False and Misleading
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.