510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944234Substantially Equivalent

Tcd or Tcd Neuropathy Star

Jcm Management & Planning Co., Wilmington DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944234 is the FDA 510(k) clearance record for TCD OR TCD NEUROPATHY STAR, a class I device, cleared for Jcm Management & Planning Co. on under FDA product code GWI (Discriminator, Two-Point). FDA records list one 510(k) clearance for Jcm Management & Planning Co. As of , FDA records show no recalls naming K944234.

Clearance record

Decision date
Received
(189 days to decision)
Product code
GWI Discriminator, Two-Point
Regulation
21 CFR 882.1200
Device class
Class I
Review panel
Neurology
Applicant
Jcm Management & Planning Co. 117 Parrish Ln., Wilmington DE
510(k) summary
Statement
Third party review
No

Clearances, product code GWI

Trailing 12 months

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

FDA records show no clearances under product code GWI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWI, 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