Shokz Health Global Limited is one of 23 FDA 510(k) medical device manufacturers from Hong Kong in the dataset, ranked by real submission volume.
Shokz Health Global Limited - FDA 510(k) Cleared Devices
Recent clearances: Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
1
Total
1
Cleared
0
Denied
Shokz Health Global Limited has 1 FDA 510(k) cleared medical devices. Based in Kowloon, HK.
Latest FDA clearance: Aug 2026. Active since 2026. Primary specialty: Ear, Nose, Throat.
Browse the FDA 510(k) cleared devices submitted by Shokz Health Global Limited Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Shokz Health Global Limited
1 devices