Ergoselect/GE
510(k) K112121
Ergoselect/GE is a medical device (FDA Class II; FDA product code ISD, Exerciser, Measuring) made by ergoline GmbH, cleared under FDA 510(k) K112121 on 31 Oct 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112121 | Date31 Oct 2012 | StatusActive |
Official records
- FDA 510(k) database K112121
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ISD
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5360
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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