FDA 510(k)

真非手术脊椎减压系统（DRX9000-SL）

K号: K243775 · 2025-07-18

决定日期2025-07-18

产品代码ITH

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决定实质等同

器械摘要

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.

常见问题

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.

列明Excite Medical of Tampa Bay, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243366DRX9000C-SL 颈椎椎间盘减压系统

官方来源

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