Z-0970-2011

RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of disposable adhesive patches...

Name: Z-0970-2011 RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of disposable adhesive patches...
Creator: Sleep Modus
Published: 2010-09-15
License: https://open.fda.gov/license/

Sleep Modus, Inc. / initiated 2010-09-15 / Terminated

FDA source

Sleep Modus began a recall of RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of disposable adhesive patches applied to the dorsum of the feet. Each patch contains a... on 2010-09-15. The reason FDA records is "Device had no 510(k) clearance prior to patient use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0970-2011
Status: Terminated
Initiated: 2010-09-15
Posted: 2011-01-27
Terminated: 2011-01-31
Recalling firm: Sleep Modus, Inc.
Product: RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of disposable adhesive patches applied to the dorsum of the feet. Each patch contains a microprocessor, memory, movement sensor, and a small coin-type battery. The devices record periodic movements of the feet and legs during the night.
Reason for recall: Device had no 510(k) clearance prior to patient use.
FDA root cause: Other
Action: Sleep Modus, Inc. notified consignees by e-mail on 9/15/2010 and 10/7/2010. The e-mail identified the product, the problem, and the action to be taken. Customers were instructed to let them know if they experienced any of the issues identified in the e-mail. For questions call 214-405-4055.
Quantity in commerce: 110 devices (2 per kit)
Distribution: Nationwide Distribution including Texas
Product codes and lots: Model Proto6, Rev-J Firmware; and Protypes 1-5 Various

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)