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
K981885Substantially Equivalent

Sunrise Scooter Series, Model Unassigned, 3 Wheel Standard Model, 3 Wheel Mid Range Model, 3 Wheel High End Model, 4 Whe

Sunrise Medical, Inc., Longmont CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981885 is the FDA 510(k) clearance record for SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE, a class II device, cleared for Sunrise Medical, Inc. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list 45 510(k) clearances for Sunrise Medical, Inc., from to . As of , FDA records show no recalls naming K981885.

Clearance record

Decision date
Received
(167 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Sunrise Medical, Inc. 7477 E. Dry Creek Pkwy., Longmont CO
510(k) summary
Summary
Third party review
No

Clearances, product code INI

Trailing 12 months
22 clearances under product code INI in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code INI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20265
February 20262
March 20262
April 20261
May 20261
June 20262
July 20262
August 20262
September 20262
October 20260