# K083322: Neurometrix Bioamplifier

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: May 27, 2009 after 196 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- 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 K922488 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073415: Nemus System; Nemus PC Peripheral, Eb Neuro S.P.A. (2008) Summary page 1.

## Indications for use
The NeuroMetrix Bioamplifier us intended for amplification and transmission of the electrical activity of peripheral nerves and muscles recorded through surface electrodes.

Source page: https://510kreport.com/device/K083322
Methodology: https://510kreport.com/methodology