Motive®腰背肌刺激器（OT01-1003）
K号: K253478 · 2025-11-06
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决定日期2025-11-06
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
Motive™ Muscle Stimulator for Lower Back (OT01-1003) is the device name listed in this FDA 510(k) record. The listed applicant is Motive Health, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K253478. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Motive™ Muscle Stimulator for Lower Back (OT01-1003)?
Motive™ Muscle Stimulator for Lower Back (OT01-1003) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Motive Health, Inc.. The 510(k) number is K253478.
When did Motive™ Muscle Stimulator for Lower Back (OT01-1003) receive FDA 510(k) clearance?
Motive™ Muscle Stimulator for Lower Back (OT01-1003) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K253478.
Who is the listed applicant for Motive™ Muscle Stimulator for Lower Back (OT01-1003)?
The FDA 510(k) record lists Motive Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Motive™ Muscle Stimulator for Lower Back (OT01-1003)?
The FDA product code for Motive™ Muscle Stimulator for Lower Back (OT01-1003) is NGX.
相关临床试验
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相关器械（代码：NGX）
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。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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