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510(k) K143512

ActiSpec Activity Monitor by Sleep Modus, Inc. — Product Code ISD

K143512 is an FDA 510(k) premarket notification submitted by Sleep Modus, Inc. for the device "ActiSpec Activity Monitor". The FDA issued a decision of Substantially Equivalent on August 26, 2015. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2015
Date Received
December 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

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FDA data resources