510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K925247Substantially Equivalent

Stoneheart Roller Aid

Stoneheart, Inc., Cheney WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925247 is the FDA 510(k) clearance record for STONEHEART ROLLER AID, a class I device, cleared for Stoneheart, Inc. on under FDA product code INM (Chair, With Casters). FDA records list one 510(k) clearance for Stoneheart, Inc. As of , FDA records show no recalls naming K925247.

Clearance record

Decision date
Received
(119 days to decision)
Product code
INM Chair, With Casters
Regulation
21 CFR 890.3100
Device class
Class I
Review panel
Physical Medicine
Applicant
Stoneheart, Inc. 224 2nd St., Box 329, Cheney WA
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