FDA 510(k) · Sleep Performance (dba Fatigue Science)
K111514: SBV2, MULTICHARGER MODEL MC10V2 (Sleep Performance D.B.A. Fatigue Science)
Sleep Performance D.B.A. Fatigue Science received FDA 510(k) K111514 for SBV2, MULTICHARGER MODEL MC10V2, with a decision date of Dec 16, 2011 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K111514 |
|---|---|
| Pathway | 510(k) |
| Applicant | Sleep Performance D.B.A. Fatigue Science |
| Device name | SBV2, MULTICHARGER MODEL MC10V2 |
| Product code | LEL: Device, Sleep Assessment |
| Regulation (21 CFR) | 882.5050 |
| Device class | Class 2 |
| Date received | Jun 1, 2011 |
| Decision date | Dec 16, 2011 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Statement 510(k) Number (if known) K 111514 Device Name SBV2 System Indications The SBV2 System is an activity monitor designed and intended for for Use documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze limb activity associated with movement during sleep and to extract information about certain sleep parameters from these movements. SBV2 can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable. The use of SBV2 is indicated for adults 22 years of age and over. Prescription Use AND/OR_ Over-The-Counter Use ___X__ (Part 21 CFR 801 Subpart D) AN/R(21 FR 80 1 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRI-I, Office of Device Evaluation (ODE) - jov Page I of I (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Troat Devices 510(k) Number ~j~~
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
Later records that cite K111514
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code LEL is "Device, Sleep Assessment", class 2, 21 CFR 882.5050.
Our labels for filtering: claim Sleep, sensor Other. These are heuristics, not FDA fields.