← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

PBX — Massager, Vacuum, Radio Frequency Induced Heat

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4400
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
16
510(K)/PMA CLEARANCES
510k: 16
0
RECALL ENTRIES

Recent clearances

K253480Capenergy Medical S.L. · 510k2026-07-10
K260647El.En S.P.A. · 510k2026-04-02
K253261Weero Co., Ltd. · 510k2026-03-13
K252888S&M Medical Co., Ltd. · 510k2026-03-09
K250734Pollogen, Ltd. · 510k2025-09-10
K250916Shenzhen Leaflife Technology Co., Ltd. · 510k2025-08-14
K243716Termosalud S.L. · 510k2025-05-28
K241733Novasonix Technology S.L. · 510k2025-04-16

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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