Cleared Traditional

K222703 - ATTO Mobility Scooter (ATTO) (FDA 510(k) Clearance)

Also includes:
ATTO Mobility Scooter (ATTO SPORT) ATTO Mobility Scooter (ATTO SPORT MAX)
May 2023
Decision
254d
Days
Class 2
Risk

K222703 is an FDA 510(k) clearance for the ATTO Mobility Scooter (ATTO). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).

Submitted by Moving Life, Ltd. (Netzer Sereni, IL). The FDA issued a Cleared decision on May 19, 2023, 254 days after receiving the submission on September 7, 2022.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K222703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2022
Decision Date May 19, 2023
Days to Decision 254 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code INI - Vehicle, Motorized 3-wheeled
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.3800

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