FDA 510(k) · AliveCor
K232035: Impala (AliveCor, Inc.)
AliveCor, Inc. received FDA 510(k) K232035 for Impala, with a decision date of Jun 7, 2024 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K232035 |
|---|---|
| Pathway | 510(k) |
| Applicant | AliveCor, Inc. |
| Device name | Impala |
| Product code | DPS: Electrocardiograph |
| Regulation (21 CFR) | 870.2340 |
| Device class | Class 2 |
| Date received | Jul 7, 2023 |
| Decision date | Jun 7, 2024 |
| 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
Impala is intended to record, store, and transfer a 12-lead resting electrocardiogram (ECG). Impala acquires four standard diagnostic-bandwidth leads (Leads I, II, V2, V4, or Leads I, II, V1, V4). The device derives four standard diagnostic- bandwidth, Lead-III and unipolar limb leads aVR, aVF and aVL. The device also synthesizes Leads V1 or V2, V3, V5, V6, which are similar to but not identical to the same leads of a standard diagnostic 12-lead. The 4 synthesized chest leads are not intended for diagnostic use and may fail to show important findings limited to those leads. This device is not a substitute for a diagnostic 12-lead ECG and is contraindicated for use in ruling out any condition (including but not limited to certain ischemia/infarcts, Brugada syndrome) for which the diagnosis may be solely dependent on the synthesized leads. The device also provides ECG measurements and ECG analysis (rhythm and morphological interpretation) using the acquired leads. The automated ECG analysis results are provisional and should not be used for clinical action if it has not been reviewed by a qualified physician capable of independently interpreting the ECG signal in the context of the patient's condition. The automated analysis may then be confirmed, edited, or deleted by a qualified physician. ECG analysis should be used only as an adjunct to clinical history, symptoms, and the results of other non-invasive and/or invasive tests. Impala is intended for use with patients aged 18 years and older. Impala is intended for use by healthcare professionals, or trained personnel in healthcare facilities (e.g. the doctor’s office or hospital) and in acute settings.
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 DPS is "Electrocardiograph", class 2, 21 CFR 870.2340.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.