510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990766Substantially Equivalent

Cersr Electromyography System

Paraspinal Diagnostic Corp., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990766 is the FDA 510(k) clearance record for CERSR ELECTROMYOGRAPHY SYSTEM, a class II device, cleared for Paraspinal Diagnostic Corp. on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list one 510(k) clearance for Paraspinal Diagnostic Corp. As of , FDA records show one recall naming K990766.

Clearance record

Decision date
Received
(172 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Paraspinal Diagnostic Corp. 11605 Hitching Post Ln., Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code IKN

Trailing 12 months

FDA records hold no clearances under product code IKN in the trailing twelve months.

FDA records show no clearances under product code IKN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260