# K100266: Actiwave 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, Actiwave Cardio Model 08-514, 08-521, 08-536, 08-557, 08-603

- Pathway: 510(k) (Abbreviated)
- Applicant: Camntech, Ltd.
- Decided: Apr 29, 2010 after 90 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001317 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021470: Seer Light Compact Digital Holter Recorder, General Electric Medical Systems Information Techn (2002) Summary page 1.

## Indications for use
The Actiwave Recorder is an ambulatory, body-worn, dermally-affixed, physiological signal and activity recorder. Actiwave is indicated for use in recording physiological waveforms and activity as part of a physiological recording system. The subject is not restricted to a medical environment. The subject may participate in normal activities wxhile the Actiwave recorder is in place. Actixvave is a multi-use recorder. Actiwave may be used wherever quantifiable measurement of human physiological signal waveforms and/or activity are needed. Actiwave may be used in a clinical setting or in basic scientific research under the supervision of a trained clinician.

Source page: https://510kreport.com/device/K100266
Methodology: https://510kreport.com/methodology