510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sleep Modus, Inc.

Richardson, TX, US

Sleep Modus, Inc. appears in FDA device records in Richardson, TX. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Sleep Modus, Inc. in 2015.

Clearances by year, as a table
510(k) clearance decisions for Sleep Modus, Inc., by decision year
YearClearances
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K143512ActiSpec Activity MonitorISDSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0970-2011RLSense, 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.Device had no 510(k) clearance prior to patient use.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain