SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
by Eurogreen International Inc.
510(k) K173313
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK173313 | Date13 Feb 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- ITI
- FDA applicant
- Eurogreen International, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The SupaChair Powered Wheelchair is a motorised mobility device designed for individuals requiring powered assistance. It falls under the category of powered wheelchairs, providing enhanced mobility for users with limited ambulatory capacity, often in clinical or home settings.
These models are supplied as reusable devices, intended for long-term use in clinical environments such as physical medicine rehabilitation centres. The COMBI 18 and COMBI 20 series feature different seating configurations (standard and SP variants), with regulatory authorisations including FDA 510K clearance and MDR compliance. Storage and maintenance requirements are manufacturer-specific, adhering to standard practices for powered mobility equipment.
Other devices from Eurogreen International Inc.
Questions
AI-generated answers, 18 Sep 2026
What are the key differences between the COMBI 18 and COMBI 20 series in terms of seating configurations?
The COMBI 18 and COMBI 20 series differ primarily in their seating configurations, with both series offering standard and SP (special) variants. The SP variants likely cater to specific user needs, such as enhanced support or adjustability, though the exact distinctions between standard and SP are not detailed in the provided data. Both series are designed for powered mobility assistance in clinical or home settings for individuals with limited ambulatory capacity.
Are these powered wheelchairs intended for single-use or reusable in clinical settings?
The SupaChair Powered Wheelchair models (COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP) are explicitly described as reusable devices, intended for long-term use in clinical environments like physical medicine rehabilitation centers. They are not single-use items and are meant to be maintained and serviced over extended periods.
What regulatory pathways have been followed for these powered wheelchairs?
The SupaChair Powered Wheelchair series has undergone regulatory review through FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming their conformity with applicable standards in the U.S. and EU markets. The submission was reviewed by the FDA’s Physical Medicine (PM) Advisory Committee under the Traditional 510(k) pathway, with a decision dated February 13, 2018.
How should these wheelchairs be stored and maintained according to the manufacturer’s guidelines?
Storage and maintenance requirements for the SupaChair Powered Wheelchair are manufacturer-specific, adhering to standard practices for powered mobility equipment. While exact instructions aren’t provided, typical guidelines for such devices include keeping them in a clean, dry environment, following the manufacturer’s service intervals, and ensuring proper battery care. Always refer to Eurogreen International’s official documentation for precise protocols.