FDA 510(k) · Nanowear
K212160: SimpleSENSE Platform (Nanowear, Inc.)
Nanowear, Inc. received FDA 510(k) K212160 for SimpleSENSE Platform, with a decision date of Sep 22, 2021 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K212160 |
|---|---|
| Pathway | 510(k) |
| Applicant | Nanowear, Inc. |
| Device name | SimpleSENSE Platform |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Jul 12, 2021 |
| Decision date | Sep 22, 2021 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The SimpleSENSE Platform is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; and e) other validated data sources. The SimpleSENSE Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE Platform is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The SimpleSENSE Platform does not produce alarms and is not intended for active patient monitoring (real-time). The SimpleSENSE Platform is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The SimpleSENSE Platform is not intended for use in the presence of a pacemaker.
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.
- K201669 SimpleSENSE (Nanowear)
Later records that cite K212160
- K232053 SimpleSense-BP, SimpleSense-BP Software Application (Nanowear, Dec 8, 2023, DXN)
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 DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.