FDA 510(k) · Nanowear
K161431: SimplECG (Nanowear, Inc.)
Nanowear, Inc. received FDA 510(k) K161431 for SimplECG, with a decision date of Nov 30, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K161431 |
|---|---|
| Pathway | 510(k) |
| Applicant | Nanowear, Inc. |
| Device name | SimplECG |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | May 24, 2016 |
| Decision date | Nov 30, 2016 |
| 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 for the predicate devices are not identical. However, the differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the SimplECG relative to the predicate. Both the SimplECG device and the predicate devices have the same intended use for capturing and displaying electrocardiogram signals. Continued on next page 2
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.
Later records that cite K161431
- K201669 SimpleSENSE (Nanowear, Nov 6, 2020, DXH)
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.