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Sleep Modus, Inc.

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sleep Modus, Inc. makes

Sleep Modus, Inc. manufactures the ActiSpec Activity Monitor, a device designed to track and analyze physical activity and sleep patterns for clinical or research use.

The ActiSpec Activity Monitor is classified as a Class II medical device in the US and is listed under FDA 510(k) clearance. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • ActiSpec Activity Monitor Ref K143512

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Sleep Modus, Inc., initiated on 2010-09-15. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2010

    • 15 Sep 2010 Z-0970-2011 Unclassified (pre-2012) Terminated Device had no 510(k) clearance prior to patient use. Distribution: Nationwide Distribution including Texas

Frequently asked questions

How many devices does Sleep Modus, Inc. have in the registry?

The registry currently lists 1 device for Sleep Modus, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sleep Modus, Inc.'s devices?

Among its 1 most recently registered device, Sleep Modus, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Sleep Modus, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Sleep Modus, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sleep Modus, Inc.?

FDA recall records list 1 recall initiated by Sleep Modus, Inc., the most recent initiated on 15 Sep 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sleep Modus, Inc. in the registry?

The most recently registered devices listed for Sleep Modus, Inc. include ActiSpec Activity Monitor.

Generated automatically from registry data and not verified by a human reviewer.