# K974385: MLS Electromyographic Preamplifier

- Pathway: 510(k) (Traditional)
- Applicant: Motion Lab Systems, Inc.
- Decided: Feb 19, 1998 after 90 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
Longest line of descent: 1 generation back to K952655 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952655: B & L Electrode, B & L Engineering (1995) Summary page 1.

## Indications for use
The MLS [Electromyographic preamplifier enables researchers to acquire EMG signais from active subjects. Itis intended to be used in hospital, university and other research facilities tp acquire EMG signals for display and analysis by, or under the ction of, a health care professional.

Source page: https://510kreport.com/device/K974385
Methodology: https://510kreport.com/methodology