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FDA PMA

Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief

PMA Number: P190021 · 2025-06-20

ApplicantMainstay Medical Limited
Decision Date2025-06-20
PMA NumberP190021
Product CodeQLK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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