← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

INI — Vehicle, Motorized 3-Wheeled

DEVICE CLASS
Class II
REGULATION
21 CFR 890.3800
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
PM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
32
510(K)/PMA CLEARANCES
510k: 32
0
RECALL ENTRIES

Recent clearances

K261232Jochu Technology Co., Ltd. · 510k2026-07-14
K261163Yongkang Ruihe Metal Product Co., Ltd. · 510k2026-07-07
K253257Jiangsu Intco Medical Products Co., Ltd. · 510k2026-06-08
K253600Yurob Rehabilitation Medical Co., Ltd. · 510k2026-06-03
K260717Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · 510k2026-05-20
K260237Wuyi Aichi Industry and Trade Co., Ltd. · 510k2026-04-22
K252813Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. · 510k2026-03-17
K253936Nanjing Mijo Technology Co., Ltd. · 510k2026-03-12

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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