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# ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH vs DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG: FDAPulse comparison

**ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH's review days of 301 is 1.3x DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG's 240 (96th percentile). ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH is dated 2026-09-22; DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG 2026-09-11.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA (510(k) clearances and device enforcement reports) Copy citation

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## How does ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH compare to DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG?

| Field | ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH | DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K253762 | K260115 |
| Device | ErgoSteel (ES0001/696) | DRIM-Nail System |
| Applicant | Strongback Mobility AG C/O Blueaudit GmbH | 41Medical AG |
| Specialty / panel | Other | Other |
| Product code | IOR | |
| Device class | 1 | |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-11-25 | 2026-01-14 |
| Decision date | 2026-09-22 | 2026-09-11 |
| Review time (days) | 301 | 240 |
| Third-party review | No | No |
| Applicant location | Pfaeffikon, CH | Bettlach, CH |
| amount percentile | 96th | 77th |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 42/100 |
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Official records: [ErgoSteel (ES0001/696) (K253762): 510(k) cleared for Strongback Mobility AG C/O Blueaudit GmbH](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253762) · [DRIM-Nail System (K260115): 510(k) cleared for 41Medical AG](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260115)

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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