510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K033559Substantially Equivalent

12-Lead Glove

Ineedmd, Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033559 is the FDA 510(k) clearance record for 12-LEAD GLOVE, a class II device, cleared for Ineedmd on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list one 510(k) clearance for Ineedmd. As of , FDA records show no recalls naming K033559.

Clearance record

Decision date
Received
(406 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Ineedmd 860 Canal St., Stamford CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

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