510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840107Substantially Equivalent

Tube-Bandage for Human Digits 200

Zens Health Care Products, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840107 is the FDA 510(k) clearance record for TUBE-BANDAGE FOR HUMAN DIGITS 200, a class I device, cleared for Zens Health Care Products on under FDA product code FQM (Bandage, Elastic). FDA records list one 510(k) clearance for Zens Health Care Products. As of , FDA records show no recalls naming K840107.

Clearance record

Decision date
Received
(106 days to decision)
Product code
FQM Bandage, Elastic
Regulation
21 CFR 880.5075
Device class
Class I
Review panel
General Hospital
Applicant
Zens Health Care Products 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FQM

Trailing 12 months

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

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