FDA 510(k)

加熱腰椎舒緩墊 (型號：AST-622, AST-622B, AST-623, AST-623B)

K 號：K211942 · 2021-12-13

申請人Shenzhen Osto Technology Company Limited

決定日期2021-12-13

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K211942. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)?

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K211942.

When did Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) receive FDA 510(k) clearance?

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) received FDA 510(k) clearance on 2021-12-13, under 510(k) number K211942.

Who is the listed applicant for Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)?

The FDA 510(k) record lists Shenzhen Osto Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)?

The FDA product code for Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) is NGX.

其他以 Shenzhen Osto Technology Company Limited 為申請人之記錄

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相關器械（代碼：NGX）

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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