Bodytronic 200
510(k) K123921
Bodytronic 200 is a Class II device made by Bauerfeind AG, cleared under FDA 510(k) K123921 on 26 Apr 2013, 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 | NumberK123921 | Date26 Apr 2013 | StatusActive |
Official records
- FDA 510(k) database K123921
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOM
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2780
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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