510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K901586Substantially Equivalent

Tri-Rolls Rear Wheel Drive Powered Scooter

Invacare GmbH, Elyria OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901586 is the FDA 510(k) clearance record for TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER, a class II device, cleared for Invacare Corp. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list 131 510(k) clearances for Invacare Corp., from to . As of , FDA records show no recalls naming K901586.

Clearance record

Decision date
Received
(12 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Invacare Corp. 899 Cleveland St., Elyria OH
Third party review
No

Clearances, product code INI

Trailing 12 months
23 clearances under product code INI in the twelve months to November 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code INI, trailing twelve months
MonthClearances
December 20252
January 20265
February 20262
March 20262
April 20261
May 20261
June 20262
July 20262
August 20262
September 20264
October 20260
November 20260