# K990766: Cersr Electromyography System

- Pathway: 510(k) (Traditional)
- Applicant: Paraspinal Diagnostic Corp.
- Decided: Aug 27, 1999 after 172 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: 1 (0 Class I)
- 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 its predicate without a number.
- (no number) Synergy Multimedia EMG/EP, Teca Corporation: named in the summary without a submission number
- (no number) Advantage 3000 series, Advantage Medical Division of CME Telemetrix: named in the summary without a submission number
- (no number) Sierra Console, Cadwell Laboratories: named in the summary without a submission number
- (no number) Compass PortaBook II, Nicolet Biomedical: named in the summary without a submission number

## Recalls of this device
- Jan 29, 2010 · Not classified · Z-1935-2010: A full design review of the CERSR system was conducted in 7/2009. The audit revealed numerous design verification tests that either did not pass or did not meet the design input requirement. One requi

## Indications for use
The CERSR™ Electromyography System is used to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.

Source page: https://510kreport.com/device/K990766
Methodology: https://510kreport.com/methodology