FDA 510(k)

ErgoSteel (ES0001/696)

Número K: K253762 · 2026-09-22

RequerenteStrongback Mobility AG C/O Blueaudit GmbH

Data da decisão2026-09-22

Código do produtoIOR

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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