FDA 510(k) · Pneumowave
K243513: DCM (PW-DCM) (Pneumowave, Ltd.)
Pneumowave, Ltd. received FDA 510(k) K243513 for DCM (PW-DCM), with a decision date of Apr 16, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K243513 |
|---|---|
| Pathway | 510(k) |
| Applicant | Pneumowave, Ltd. |
| Device name | DCM (PW-DCM) |
| Product code | LEL: Device, Sleep Assessment |
| Regulation (21 CFR) | 882.5050 |
| Device class | Class 2 |
| Date received | Nov 12, 2024 |
| Decision date | Apr 16, 2025 |
| 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
DCM is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. DCM is indicated for monitoring of adult patients only.
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 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.