ErgoSteel (ES0001/696)— 510(k) K253762
Substantially EquivalentStrongback Mobility AG C/O Blueaudit GmbH
FDA 510(k) clearance K253762 for ErgoSteel (ES0001/696), Substantially Equivalent on 2026-09-22. Applicant: Strongback Mobility AG C/O Blueaudit GmbH. Device class: 1.
Summary
ErgoSteel (ES0001/696) is a manual wheelchair, filed under IOR, mechanical wheelchairs. The record doesn't give specs beyond the name and model number.
This is a Class I device under 21 CFR 890.3850. The Physical Medicine panel reviewed it as a Traditional 510(k).
The applicant is listed as Strongback Mobility AG, care of Blueaudit GmbH, in Pfaeffikon, Switzerland. Review took 301 days (November 25, 2025 to September 22, 2026).
Clearance details
- Applicant
- Strongback Mobility AG C/O Blueaudit GmbH
- Product code
- Product code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pfaeffikon, CH
Recent devices under product code IOR
view allAdverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.