FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT
K Number: K102088
·
Decision Oct 20, 2010
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
28
Applicant Total
2
Review Days
86
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Basic Information
- Device Name
- JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT
- K Number
- K102088
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.3930
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thyssenkrupp Ceteco Srl
- Date Received
- July 26, 2010
- Decision Date
- October 20, 2010
- Product Code
- ING
- 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 |
|---|---|---|---|
| ING | Elevator, Wheelchair, Portable | FDA class 2 | Physical Medicine |
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Other Clearances by Thyssenkrupp Ceteco Srl
| K Number | Device Name | ||
|---|---|---|---|
| K090856 | JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) | May 27, 2009 | Substantially Equivalent |