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FDA 510(k)

Flexx Junior (FLX-J00, FLX-J50)

K-Number: K250576 · 2025-11-04

ApplicantKarma Mobility Co, Ltd.
Decision Date2025-11-04
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Flexx Junior (FLX-J00, FLX-J50) is a medical device manufactured by Karma Mobility Co, Ltd.. It received FDA 510(k) clearance on 2025-11-04 under approval number K250576. 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 Flexx Junior (FLX-J00, FLX-J50)?

Flexx Junior (FLX-J00, FLX-J50) is a medical device that received FDA 510(k) clearance on 2025-11-04. It is manufactured by Karma Mobility Co, Ltd.. The 510(k) number is K250576.

When was Flexx Junior (FLX-J00, FLX-J50) approved by the FDA?

Flexx Junior (FLX-J00, FLX-J50) received FDA 510(k) clearance on 2025-11-04, under approval number K250576.

What company makes Flexx Junior (FLX-J00, FLX-J50)?

Flexx Junior (FLX-J00, FLX-J50) is manufactured by Karma Mobility Co, Ltd..

What is the FDA product code for Flexx Junior (FLX-J00, FLX-J50)?

The FDA product code for Flexx Junior (FLX-J00, FLX-J50) is IOR.

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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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