510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K110048Substantially Equivalent

Cersr Electromyography System

Spinematrix, Inc., Philedelphia PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110048 is the FDA 510(k) clearance record for CERSR ELECTROMYOGRAPHY SYSTEM, a class II device, cleared for Spinematrix, Inc. on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list one 510(k) clearance for Spinematrix, Inc. As of , FDA records show no recalls naming K110048.

Clearance record

Decision date
Received
(20 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Spinematrix, Inc. 1835 Market St., 29th Floor, Philedelphia PA
510(k) summary
Summary PDF
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