# K023147: Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models Amt-16, Amt-8 & Amt-4

- Pathway: 510(k) (Traditional)
- Applicant: Bortec Biomedical, Ltd.
- Decided: Dec 12, 2002 after 83 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Bortec Biomedical Analog Multiplexed cable Telemetry (AMT) electromyograph is intended for non-invasive use as a research or diagnostic sensin and processing instrument in studies of physiological signafs. The AMT is indicated for use with active or assive adult or ediatric subjects in hospitals or clinics under $e direction of a ealth care professional during electromyography, including bio-feedback, evoked potential, kinesiological, nerve conductance and sleep studies.

Source page: https://510kreport.com/device/K023147
Methodology: https://510kreport.com/methodology