DEVICE CLASS
Class II
REGULATION
21 CFR 890.5850
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
PM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K253542Weero Co., Ltd. · 510k2026-06-08
K252816Mohammadali Nezakati · 510k2026-06-02
K260142Motion Informatics ltd. · 510k2026-05-27
K251083Enraf-Nonius, B.V. · 510k2025-09-12
K241433Weero Co., Ltd. · 510k2025-06-04
K241488Trainfes · 510k2025-02-05
K240348Quantumtx Pte. , Ltd. · 510k2024-12-19
K240992Weero Co., Ltd. · 510k2024-10-10
Related on SPEQ
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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