Class Class II
Unipro (K-UNIPRO-US) (K232441)
Description
Unipro (K-UNIPRO-US) by Tenscare, Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK232441
Clearance Date2024-08-30
Clearance TypeTraditional
Product CodeGZJ
Regulation Number882.5890
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K232441
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Unipro (K-UNIPRO-US) (K232441) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K120054 | ULTIMA NEO | Pain Management Technologies | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | 2025 |
Trace the full predicate network for K232441
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.