← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

QLK — Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

Stimulation of nerves that innervate muscles to treat or aid in the management of chronic, intractable lower back pain.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
NE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P190021Mainstay Medical Limited · pma2025-06-20

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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