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FDA 510(k)

ErgoSteel (ES0001/696)

K-Number: K253762 · 2026-09-22

ApplicantStrongback Mobility AG C/O Blueaudit GmbH
Decision Date2026-09-22
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ErgoSteel (ES0001/696) is the device name listed in this FDA 510(k) record. The listed applicant is Strongback Mobility AG C/O Blueaudit GmbH. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K253762. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ErgoSteel (ES0001/696)?

ErgoSteel (ES0001/696) is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Strongback Mobility AG C/O Blueaudit GmbH. The 510(k) number is K253762.

When did ErgoSteel (ES0001/696) receive FDA 510(k) clearance?

ErgoSteel (ES0001/696) received FDA 510(k) clearance on 2026-09-22, under 510(k) number K253762.

Who is the listed applicant for ErgoSteel (ES0001/696)?

The FDA 510(k) record lists Strongback Mobility AG C/O Blueaudit GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ErgoSteel (ES0001/696)?

The FDA product code for ErgoSteel (ES0001/696) is IOR.

Related Devices (Code: IOR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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