Karma Scooter, Model KS-747.2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K041677 FDA 510(k)
- FDA Product Code
- INI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3800 FDA 510(k)
- Regulation Number
- 890.3800 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Karma Scooter, Model KS-747.2 is a motorized 3-wheeled vehicle classified under device class 2. It is designed as a power scooter for mobility assistance, featuring a 4-pole motor for stable output and strong torque, which helps reduce motor wear and tear. The device includes a hydraulic front-wheel suspension system and a widened rear wheelbase to enhance overall stability.
It is suitable for seniors with limited mobility or individuals with difficulty walking long distances, and is ideal for long-distance travel, climbing uphill, and high-speed operation. The scooter is supplied as a non-sterile, reusable device intended for use in home or community settings. It received FDA 510(k) clearance (K041677) on August 5, 2004, as substantially equivalent to a predicate device, under the Physical Medicine advisory committee review, and is regulated under regulation number 890.3800 with product code INI.
Frequently asked questions
What is the Karma Scooter KS-747.2 intended for?
The Karma Scooter KS-747.2 is designed as a power scooter for mobility assistance, suitable for seniors with limited mobility or individuals who have difficulty walking long distances, and is ideal for long-distance travel, uphill climbing, and high-speed operation.
How is the Karma Scooter KS-747.2 supplied and is it reusable?
The device is supplied as a non-sterile, reusable device intended for use in home or community settings, meaning it is not provided in a sterile condition and is designed for multiple uses over time with appropriate maintenance.
What features contribute to the stability of the Karma Scooter KS-747.2?
The scooter includes a hydraulic front-wheel suspension system and a widened rear wheelbase, which together enhance overall stability during operation, particularly on uneven terrain or during turns.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: KS-747.2 Mid-range Power Scooter | KARMA Medical, KS-747.2 | KARMA Medical India - Karma Healthcare, 4-wheel electric scooter KS-747.2 Karma Medical Products Co., Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041677 | Class II | Active |
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Manufacturer
- Manufacturer
- Karma Medical Products Co., Ltd.
Sources (1)
- FDA 510(k) K041677 24 fields · synced Oct 6, 2026