FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR
K Number: K850877
·
Decision Jun 12, 1985
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
35
Applicant Total
10
Review Days
103
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Basic Information
- Device Name
- MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR
- K Number
- K850877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5150
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Ketronic, Inc.
- Date Received
- March 1, 1985
- Decision Date
- June 12, 1985
- Product Code
- ILK
- 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 |
|---|---|---|---|
| ILK | Transport, Patient, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Ketronic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K850876 | LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR | May 16, 1985 | Substantially Equivalent |
| K850875 | ACTION-WHEELS & PLAY WHEELS | May 16, 1985 | Substantially Equivalent |
| K843288 | KETRONIC MEDAX - N | Nov 8, 1984 | Substantially Equivalent |