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The Tracker / September 2026 / K253762

510(k) cleared

ErgoSteel (ES0001/696)

Strongback Mobility AG C/O Blueaudit GmbH · Sep 22, 2026 · K253762

FDA cleared the ErgoSteel (ES0001/696) from Strongback Mobility AG C/O Blueaudit GmbH on Sep 22, 2026 under K253762, a traditional 510(k). The device falls under product code IOR, Wheelchair, Mechanical, regulated at 21 CFR 890.3850 as a Class 1 device. The review panel was Physical Medicine.

FDA logged the submission as received on Nov 25, 2025. The decision came 301 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Strongback Mobility AG C/O Blueaudit GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253762?

K253762 is the FDA 510(k) for ErgoSteel (ES0001/696), submitted by Strongback Mobility AG C/O Blueaudit GmbH. FDA's decision date was Sep 22, 2026, under product code IOR (Wheelchair, Mechanical).

Who makes the ErgoSteel (ES0001/696)?

Strongback Mobility AG C/O Blueaudit GmbH, based in Pfaeffikon, is the applicant of record for K253762.

How long did the K253762 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Sep 22, 2026, 301 days later.

← All decisions in September 2026