510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921917Substantially Equivalent

Dolomite Rollator

Seamark Technologies, Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921917 is the FDA 510(k) clearance record for DOLOMITE ROLLATOR, a class I device, cleared for Seamark Technologies on under FDA product code INM (Chair, With Casters). FDA records list one 510(k) clearance for Seamark Technologies. As of , FDA records show no recalls naming K921917.

Clearance record

Decision date
Received
(33 days to decision)
Product code
INM Chair, With Casters
Regulation
21 CFR 890.3100
Device class
Class I
Review panel
Physical Medicine
Applicant
Seamark Technologies 1901 S. Ocean Blvd., Boca Raton FL
510(k) summary
Statement
Third party review
No

Clearances, product code INM

Trailing 12 months

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

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