FDA 510(k) · Perahealth
K183370: PeraMobile and PeraWatch (Perahealth, Inc.)
Perahealth, Inc. received FDA 510(k) K183370 for PeraMobile and PeraWatch, with a decision date of Sep 11, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K183370 |
|---|---|
| Pathway | 510(k) |
| Applicant | Perahealth, Inc. |
| Device name | PeraMobile and PeraWatch |
| Product code | MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Dec 4, 2018 |
| Decision date | Sep 11, 2019 |
| 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
PeraMobile Indications for Use: The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient’s physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient’s vital signs, nursing assessments, and selected lab values. PeraMobile is indicated for use by healthcare providers within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraMobile is intended for use in the hospital to support Rapid Response Team clinicians or other dedicated clinical response staff responsible for pro-actively rounding on patients of concern and/or providing supplemental support to bed- side clinicians. PeraWatch Indications for Use: The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient’s physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient’s vital signs, nursing assessments, and selected lab values. PeraWatch is indicated for use by healthcare providers whenever there is need within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraWatch is intended to support clinicians in surveilling patients throughout the hospital setting (e.g. in the emergency department, on the wards, in intensive care units) and across multiple hospitals in a centralized and/or remote professional clinical surveillance setting.
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
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.
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 MWI is "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.2300.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Wrist PPG. These are heuristics, not FDA fields.