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FDA PMA

神經肌肉刺激器,低背部肌肉,完全植入式疼痛緩解

PMA 核准號:P190021 · 2025-06-20

決定日期2025-06-20
PMA 編號P190021
產品代碼QLK
器械分類3 類
醫療專科U
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)

器材摘要

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.

常見問題

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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官方來源

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