← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

QPLElectromagnetic Stimulator, Pain Relief

Intended to apply a magnetic-field induced electrical current to treat pain.

DEVICE CLASS
Class II
REGULATION
21 CFR 882.5890
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
PM
ImplantLife-sustainingGMP-exemptThird-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K250309BTL Industries, Inc. · 510k2025-08-07
K250286The Magstim Company Limited · 510k2025-07-03
K241785Fotona D.O.O. · 510k2025-03-27

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA 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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