FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR
K Number: K850876
·
Decision May 16, 1985
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
10
Review Days
76
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
- LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR
- K Number
- K850876
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ketronic, Inc.
- Date Received
- March 1, 1985
- Decision Date
- May 16, 1985
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITI), ordered by most recent decision date.
Power Wheelchair (W5915B, W5915C, W5915D)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (S500-6)
FDA 510(k)
FDA Class 2
·Physical Medicine
WHILL (WHILL Model C2)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Wheelchair (N5515A, N5516, N5517A, N5519)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (DF506)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (Y207BL)
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Ketronic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850877 | MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR | Jun 12, 1985 | Substantially Equivalent |
| K850873 | HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL | Jun 12, 1985 | Substantially Equivalent |
| K850870 | MEDIFETTE ERGOMETER | Jun 12, 1985 | Substantially Equivalent |
| K850868 | MFE CARDIAC STRESS SYSTEM | Jun 12, 1985 | Substantially Equivalent |
| K850869 | MFE COUCH ERGOMETER | Jun 12, 1985 | Substantially Equivalent |
| K850872 | PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI | Jun 6, 1985 | Substantially Equivalent for Some Indications |
| K850871 | TREDBAND TYPE I, IT, II & III - TREADMILLS | Jun 5, 1985 | Substantially Equivalent |
| K850875 | ACTION-WHEELS & PLAY WHEELS | May 16, 1985 | Substantially Equivalent |
| K843288 | KETRONIC MEDAX - N | Nov 8, 1984 | Substantially Equivalent |