FDA 510(k) · VGBio (dba physIQ)
K142512: Personalized Physiology Analytics Engine software (Vgbio, Inc (Dba Physiq))
Vgbio, Inc (Dba Physiq) received FDA 510(k) K142512 for Personalized Physiology Analytics Engine software, with a decision date of Jun 11, 2015 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K142512 |
|---|---|
| Pathway | 510(k) |
| Applicant | Vgbio, Inc (Dba Physiq) |
| Device name | Personalized Physiology Analytics Engine software |
| Product code | PLB: Multivariate Vital Signs Index |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Sep 8, 2014 |
| Decision date | Jun 11, 2015 |
| 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
We could not extract the indications for this record. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K142512
- K183282 Biovitals Analytics Engine (Biofourmis, Aug 15, 2019, PLB)
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 PLB is "Multivariate Vital Signs Index", class 2, 21 CFR 870.2300. FDA's definition: "Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs."
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.