ActiSpec Activity Monitor— 510(k) K143512

Name: FDA 510(k) clearance K143512
Creator: U.S. Food and Drug Administration
Published: 2015-08-26

Substantially Equivalent

Sleep Modus, Inc.

FDA 510(k) clearance K143512 for ActiSpec Activity Monitor, Substantially Equivalent on 2015-08-26. Applicant: Sleep Modus, Inc.. Device class: 2.

Clearance details

Applicant: Sleep Modus, Inc.
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 2014-12-11
Decision date: 2015-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.