FDA applicant
Shenzhen Kelutongda Industrial Co., Ltd.
FDA records 1 decision for Shenzhen Kelutongda Industrial Co., Ltd. (Shenzhen, CN) in 2023: 1 510(k) clearance. All are in product code NGX (Stimulator, Muscle, Powered, For Muscle…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Kelutongda Industrial Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2023high 1 (2023) · low 0 (2024)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Shenzhen Kelutongda Industrial Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report