FDA applicant
Smartmissimo Technologies Pte, Ltd.
FDA records 5 decisions for Smartmissimo Technologies Pte, Ltd. (Singapore, SG) from 2015 to 2021: 5 510(k) clearances. Most are in product codes IPF (Stimulator, Muscle, Powered) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Smartmissimo Technologies Pte, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Smartmissimo Technologies Pte, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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