Flexx Junior (FLX-J00, FLX-J50)
K 號：K250576 · 2025-11-04
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器材摘要
Flexx Junior (FLX-J00, FLX-J50) is the device name listed in this FDA 510(k) record. The listed applicant is Karma Mobility Co, Ltd.. It received FDA 510(k) clearance on 2025-11-04 under 510(k) number K250576. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
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. The listed applicant is Karma Mobility Co, Ltd.. The 510(k) number is K250576.
When did Flexx Junior (FLX-J00, FLX-J50) receive FDA 510(k) clearance?
Flexx Junior (FLX-J00, FLX-J50) received FDA 510(k) clearance on 2025-11-04, under 510(k) number K250576.
Who is the listed applicant for Flexx Junior (FLX-J00, FLX-J50)?
The FDA 510(k) record lists Karma Mobility Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.
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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相關器械（代碼：IOR）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
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