FDA Device recall Z-1820-2012
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions…
- FDA Device
- Class II
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class II recall of USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions… by Non Invasive Monitoring Systems, citing non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1820-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-07 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Non Invasive Monitoring Systems |
| Distribution | US |
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***[email protected] 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
Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Identifiers
| code_info | Brochure USA-002 Rev A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1820-2012%22
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