FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
K Number: K053078
·
Decision Apr 27, 2006
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
60
Applicant Total
3
Review Days
176
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
- ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
- K Number
- K053078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5360
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ergoline GmbH
- Date Received
- November 2, 2005
- Decision Date
- April 27, 2006
- Product Code
- ISD
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ISD | Exerciser, Measuring | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ISD), ordered by most recent decision date.
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
FDA 510(k)
FDA Class 2
·Physical Medicine
REAL Immersive System
FDA 510(k)
FDA Class 2
·Physical Medicine
ActiSpec Activity Monitor
FDA 510(k)
FDA Class 2
·Physical Medicine
ERGOSELECT/GE
FDA 510(k)
FDA Class 2
·Physical Medicine
ACTITRAINER
FDA 510(k)
FDA Class 2
·Physical Medicine
QUINTON MEDTRACK CR PLUS TREADMILL
FDA 510(k)
FDA Class 2
·Physical Medicine