神经肌肉刺激器，用于下背部肌肉，完全植入式疼痛缓解
PMA编号：P190021 · 2025-06-20
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决定日期2025-06-20
PMA 编号P190021
产品代码QLK
设备分类第3类
医疗专科U
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
器械摘要
Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief is the device name listed in this FDA 510(k) record. The listed applicant is Mainstay Medical Limited. It received FDA 510(k) clearance on 2025-06-20. The device is classified under product code QLK. It was reviewed by the NE advisory panel.
常见问题
What is the Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief?
Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Mainstay Medical Limited.
When did Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief receive FDA 510(k) clearance?
The clearance date for Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief can be found in the official FDA records.
Who is the listed applicant for Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief?
The FDA 510(k) record lists Mainstay Medical Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief?
The FDA product code for Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief is QLK.
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官方来源
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