FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
Weely Manual Wheelchair
K Number: K152827
·
Decision Feb 19, 2016
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
1
Review Days
143
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Weely Manual Wheelchair
- K Number
- K152827
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rupiani
- Date Received
- September 29, 2015
- Decision Date
- February 19, 2016
- Product Code
- IOR
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOR), ordered by most recent decision date.
ICON 35; ICON 45; ICON 60; ICON 30FAF
FDA 510(k)
FDA Class 1
·Physical Medicine
Manual Wheelchair (LW01108)
FDA 510(k)
FDA Class 1
·Physical Medicine
Helio Kids; Apex P
FDA 510(k)
FDA Class 1
·Physical Medicine
Manual Wheelchair (DY01903(2))
FDA 510(k)
FDA Class 1
·Physical Medicine
Manual Wheelchair (7101L, 7102LHD)
FDA 510(k)
FDA Class 1
·Physical Medicine
K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
FDA 510(k)
FDA Class 1
·Physical Medicine