Z-1820-2012Class II

USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling...

Name: Z-1820-2012 USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling...
Creator: Non-Invasive Monitoring Systems, Inc.
Published: 2012-05-07
License: https://open.fda.gov/license/

Non-Invasive Monitoring Systems, Inc. / initiated 2012-05-07 / Terminated / root cause: labeling and UDI

FDA source

Non-Invasive Monitoring Systems, Inc. began a recall of USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general... on 2012-05-07. FDA classified it as Class II and gives the reason as "Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1820-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-07
Posted: 2012-06-18
Terminated: 2012-07-16
Recalling firm: Non-Invasive Monitoring Systems, Inc.
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
Product code: IRO Vibrator, Therapeutic
Reason for recall: Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
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.
Quantity in commerce: USA-002 Rev A brochure: 91
Distribution: Nationwide Distribution
Product codes and lots: Brochure USA-002 Rev A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1820-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1819-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-18
Z-1820-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-18

Product code IRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)