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Independence iBOT 3000/4000 Mobility System

by Independence Technology, LLC

PMA P020033

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P020033↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP020033 Date13 Aug 2003DecidedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1775-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010

    A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack.

    • Terminated Z-0022-05 FDA Unclassified (pre-2012) initiated 30 Aug 2004

    Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.

    • Terminated Z-1383-04 FDA Unclassified (pre-2012) initiated 1 Jul 2004

    iBOT Mobility System may tip over due to malfunction in power base.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Independence (Tm) Ibot 3000/4000 Mobility System
Generic Name
Wheelchair, stair climbing
PMA Number
FDA Product Code
IMK
Device Class
Class II
Regulation
21 CFR Part 890.3890
Advisory Committee
Physical Medicine
FDA Decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Independence iBOT 3000/4000 Mobility System is a Wheelchair, Stair Climbing (per FDA nomenclature), designed for individuals with mobility impairments who retain the use of at least one upper extremity. It provides active mobility assistance through dynamic balancing and propulsion, enabling movement across varied surfaces, inclines, obstacles, and staircases—both independently and with assistance—while also facilitating seated mobility at elevated heights and transportation of the unoccupied device.

This system is intended for use in home, work, and other environments, offering up to five primary operating functions: smooth-surface mobility, obstacle/terrain navigation, seated elevation mobility, stair ascent/descent (with or without assistance), and unoccupied transport. Supplied as a reusable, non-sterile Class II device under FDA_PMA (P020033), it adheres to IMK product coding and 890.3890 regulatory standards. No MRI safety or sterility requirements are specified, and sizing is determined by user-specific anthropometric measurements for proper fit and function.

Other devices from Independence Technology, LLC

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of environments is the Independence iBOT 3000/4000 Mobility System designed to operate in?

    The Independence iBOT 3000/4000 Mobility System is specifically designed for use in a variety of environments, including homes, workplaces, and other everyday settings. It is engineered to provide mobility assistance across smooth surfaces, inclines, obstacles, uneven terrain, and staircases—both independently and with assistance—while also enabling seated mobility at elevated heights and allowing the unoccupied device to be transported.

  • How is the Independence iBOT 3000/4000 Mobility System sized for users?

    Sizing for the Independence iBOT 3000/4000 Mobility System is determined by user-specific anthropometric measurements to ensure proper fit and function. This means the device is tailored to the individual’s body dimensions rather than using standardized sizes, allowing for optimal performance and comfort.

  • Is the Independence iBOT 3000/4000 Mobility System intended for single-use or reusable applications?

    The Independence iBOT 3000/4000 Mobility System is supplied as a reusable device. It is classified as a non-sterile Class II medical device under FDA_PMA, meaning it is designed for repeated use by the same user over time, provided it is properly maintained and cleaned as recommended.

  • What are the primary functions of the Independence iBOT 3000/4000 Mobility System?

    The Independence iBOT 3000/4000 Mobility System offers up to five primary operating functions: smooth-surface mobility, obstacle and terrain navigation (including grass, gravel, and curbs), seated elevation mobility, stair ascent and descent (with or without assistance), and the ability to transport the unoccupied device. These functions collectively aim to enhance active mobility for users with mobility impairments who retain the use of at least one upper extremity.

  • What regulatory pathway was followed for the approval of the Independence iBOT 3000/4000 Mobility System?

    The Independence iBOT 3000/4000 Mobility System was approved through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number P020033. This pathway is typically used for higher-risk medical devices, and the device falls under the product code IMK and regulatory standard 890.3890, aligning with its classification as a Wheelchair, Stair Climbing.