USA-002 Rev A brochure is a two sided tri-fold printed marketing… — Class II medical device recall Z-1820-2012
Terminated recall by Non-Invasive Monitoring Systems, Inc., reported 2012-06-27, distributed nationwide. Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubs
| Recall number | Z-1820-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Non-Invasive Monitoring Systems, Inc., Miami, FL, United States |
| Recall initiated | 2012-05-07 |
| Classified | 2012-06-18 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2012-07-16 |
| Distributed | Nationwide (US) |
| Model numbers | AT3800, AT4700 |
Product
USA-002 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. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure
Reason for recall
Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.