Class Class II
Curapuls 670 (K243112)
Description
Curapuls 670 by Enraf-Nonius, B.V., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243112
Clearance Date2025-06-25
Clearance TypeTraditional
Product CodeIMJ
Regulation Number890.5290
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243112
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. Curapuls 670 (K243112) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182363 | BTL-703 | BTL Industries, Inc. | 2019 |
Trace the full predicate network for K243112
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.