# K052060: Opti-Amp DC-Powered

- Pathway: 510(k) (Special)
- Applicant: Intelligent Hearing Systems
- Decided: Aug 31, 2005 after 33 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: 1 generation back to K914876 (1992). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914876: Opti-Amp, Intelligent Hearing Systems (1992) Summary page 1.

## Most influential descendants
- K061443: Smart Usblite, Model M011120 (2006), 1 descendant of its own
- K193033: GSI Audera Pro (2020), 0 descendants of its own

## Indications for use
The intended use of the Opti-Amp DC-Powered is as a physiological signal amplifier. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting. The anatomical site of contact is the patient's outer skin surface with electrodes placed to acquire a bio-electric surface signal.

Source page: https://510kreport.com/device/K052060
Methodology: https://510kreport.com/methodology