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FDA PRODUCT CODE · CLASS II

IRP — Massager, Powered Inflatable Tube

DEVICE CLASS
Class II
REGULATION
21 CFR 890.5650
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
PM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
25
510(K)/PMA CLEARANCES
510k: 25
0
RECALL ENTRIES

Recent clearances

K253919Xiamen Weiyou Intelligent Technology Co., Ltd. · 510k2026-06-10
K252396Avanutri Equipamentos DE Saúde · 510k2026-05-29
K254200Wenzhou Lingfeng Electronic Technology Co., Ltd. · 510k2026-05-05
K253064Xiamen Weiyou Intelligent Technology Co., Ltd. · 510k2026-04-30
K252386Chengdu Cryo-Push Medical Technology Co.,Ltd · 510k2026-04-03
K253076Chengdu Cryo-Push Medical Technology Co.,Ltd · 510k2026-04-02
K251622Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · 510k2026-01-28
K251662Shenzhen Future Electronic Co., Ltd. · 510k2025-11-13

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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