FDA PMA

스티미ュ러, 신경근육, 하背部 근육, 완전히 이식된 통증 완화용

PMA 번호: P190021 · 2025-06-20

신청자Mainstay Medical Limited

결정일2025-06-20

PMA 번호P190021

제품 코드QLK

의료기기 등급등급 3

의학적 전문분야U

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

기기 요약

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.

자주 묻는 질문

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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