Karma Manual Wheelchair S-Ergo 305 and S-Ergo 105
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K062309 FDA 510(k)
- FDA Product Code
- IOR FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3850 FDA 510(k)
- Regulation Number
- 890.3850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Karma Manual Wheelchair S-Ergo 305 and S-Ergo 105 are classified as Wheelchair, Mechanical under FDA nomenclature. These devices are manual, four-wheeled mobility aids designed to provide independent movement for individuals with limited mobility. The S-Ergo models incorporate an ergonomic seating system, adjustable components, and modular features to accommodate a range of user needs, including height-adjustable armrests and detachable footrests.
These wheelchairs are intended for indoor and outdoor use and are supplied as reusable, non-sterile medical devices. They are regulated under FDA 510(k) clearance (K062309) and the EU Medical Device Regulation (MDR), with a classification of Class I. The S-Ergo 305 and S-Ergo 105 feature foldable frames for transport and storage, though specific sterility or MRI safety ratings are not indicated in the available data. Authorized by Karma Medical Products Co., Ltd., they comply with regulatory standards for physical medicine applications.
Frequently asked questions
What are the Karma S-Ergo 305 and S-Ergo 105 manual wheelchairs designed for?
These wheelchairs are manual, four-wheeled mobility aids intended to provide independent movement for individuals with limited mobility. They feature an ergonomic seating system, adjustable components like height-adjustable armrests, and detachable footrests to accommodate a wide range of user needs. The designs prioritize usability for both indoor and outdoor environments.
Are the Karma S-Ergo 305 and S-Ergo 105 wheelchairs single-use or reusable?
These wheelchairs are supplied as reusable devices. They are not intended for single-use and are designed for repeated use by multiple individuals, provided they are cleaned and maintained according to manufacturer guidelines. Reusability is a key feature for cost-effectiveness in clinical or home settings.
Do the S-Ergo 305 and S-Ergo 105 models come with foldable frames?
Yes, both the S-Ergo 305 and S-Ergo 105 models include foldable frames. This feature makes them easier to transport and store, which is particularly useful for users who need to move the wheelchair frequently or those with limited space. The foldability does not affect their primary function as manual mobility aids.
What is the sterility status of the Karma S-Ergo 305 and S-Ergo 105 wheelchairs?
The Karma S-Ergo 305 and S-Ergo 105 manual wheelchairs are classified as non-sterile devices. They are not intended for sterile applications, such as surgical or invasive procedures. Their design and regulatory classification align with reusable medical devices used in non-sterile environments.
How do the S-Ergo 305 and S-Ergo 105 differ in terms of regulatory compliance?
Both models are regulated under the FDA 510(k) clearance process (K062309) and comply with the EU Medical Device Regulation (MDR), classified as Class I devices. They are authorized by Karma Medical Products Co., Ltd., and fall under the Physical Medicine advisory committee category. Their regulatory status confirms they meet standards for physical medicine applications without implying specific clinical indications.
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: S-ERGO 305 Sturdy Ergonomic Wheelchair | KARMA Medical, S-Ergo Series - Premium choice for more comfortable seating | KARMA Medical, Karma Manual Wheelchair, Models S-ergo 305 and S-ergo 105
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K062309 | Class I | Active |
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Manufacturer
- Manufacturer
- Karma Medical Products Co., Ltd.
Sources (2)
- FDA 510(k) K062309 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026