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Cersr Electromyography System

by Paraspinal Diagnostic Corp.

510(k) K990766

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990766 Date27 Aug 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1935-2010 FDA Unclassified (pre-2012) initiated 29 Jan 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 requirement found that it was possible for the physician to think they were reviewing one patients scan, but were actually reviewing a scan from a different patient. This event did not happen; however,

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IKN
Device Class
Class II
Regulation
21 CFR Part 890.1375
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent