FDA 510(k)

真非手術脊椎舒壓系統（DRX9000-SL）

K 號：K243775 · 2025-07-18

決定日期2025-07-18

產品代碼ITH

諮詢委員會PM

決定相當於

器材摘要

True Non-Surgical Spinal Decompression System (DRX9000-SL) is the device name listed in this FDA 510(k) record. The listed applicant is Excite Medical of Tampa Bay, LLC. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K243775. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the True Non-Surgical Spinal Decompression System (DRX9000-SL)?

True Non-Surgical Spinal Decompression System (DRX9000-SL) is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Excite Medical of Tampa Bay, LLC. The 510(k) number is K243775.

When did True Non-Surgical Spinal Decompression System (DRX9000-SL) receive FDA 510(k) clearance?

True Non-Surgical Spinal Decompression System (DRX9000-SL) received FDA 510(k) clearance on 2025-07-18, under 510(k) number K243775.

Who is the listed applicant for True Non-Surgical Spinal Decompression System (DRX9000-SL)?

The FDA 510(k) record lists Excite Medical of Tampa Bay, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for True Non-Surgical Spinal Decompression System (DRX9000-SL)?

The FDA product code for True Non-Surgical Spinal Decompression System (DRX9000-SL) is ITH.

其他以 Excite Medical of Tampa Bay, LLC 為申請人之記錄

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。

K243366DRX9000C-SL 頸椎脊椎解壓系統

相關器械（代碼：ITH）

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。

K243366DRX9000C-SL 頸椎脊椎解壓系統Excite Medical of Tampa Bay, LLC K214037Ergo-Flex Technologies 回軌 (BOTGEN1) 及頸椎軌跡 (Cervi-Trac)Ergo-Flex Technologies, LLC K222912c1TracZimmer Medizinsysteme GmbH

官方來源

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