Class Class II
SACS PRO (K243177)
Description
SACS PRO by Elastimed , Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243177
Clearance Date2024-12-23
Clearance TypeTraditional
Product CodeIRP
Regulation Number890.5650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243177
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. SACS PRO (K243177) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232300 | ElastiMed SACS | Elastimed , Ltd. | 2023 |
| K221666 | Normatec Go | NormaTec Industries, LP | 2022 |
Trace the full predicate network for K243177
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.