Cleared Traditional

K222703 - ATTO Mobility Scooter (ATTO)

Also marketed or referenced as:
ATTO Mobility Scooter (ATTO SPORT) ATTO Mobility Scooter (ATTO SPORT MAX)

K222703 is an FDA 510(k) clearance for ATTO Mobility Scooter (ATTO), manufactured by Moving Life, Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K222703 · Moving Life, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
254d
Days
Class 2
Risk

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

Submitted by Moving Life, Ltd. (Netzer Sereni, IL). The FDA issued a Cleared decision on May 19, 2023 after a review of 254 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Moving Life, Ltd. devices

FDA 510(k) Submission Details - K222703

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 115d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 116
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K222703.
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
K231472 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Jul 2023
Mobility Scooter (Models: W3431D)
K231428 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Jul 2023
Electric Scooter (Model: M2020)
K230001 · Guangdong Prestige Technology Co., Ltd. · Jul 2023
Electric Scooter (Model: S3312)
K230615 · Guangdong Prestige Technology Co., Ltd. · May 2023
Electrical Scooter, WT-T4QP2
K222729 · Wu'S Tech Co., Ltd. · Mar 2023
Mobility Scooter (Models: W3431Q, W3431R)
K222507 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Feb 2023