510(k) clearance
ErgoSteel (ES0001/696)
- 510(k) number
- K253762
- Applicant
- Strongback Mobility AG C/O Blueaudit GmbH
- Decision date
- Sep 22, 2026
- Date received
- Nov 25, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- IOR
- Device type
- Wheelchair, Mechanical
- Device class
- Class I
- Regulation
- 21 CFR 890.3850
- Advisory committee
- Physical Medicine
- Statement or summary
- Summary
- Third party
- N
- Location
- Pfaeffikon, CH