Class Class II
ManaSport+ (K222098)
Description
ManaSport+ by Manamed, Inc., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222098
Clearance Date2023-03-08
Clearance TypeTraditional
Product CodeIMI
Regulation Number890.5300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222098
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. ManaSport+ (K222098) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210284 | ManaSport | Manamed, Inc. | 2022 |
| K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | 2025 |
Trace the full predicate network for K222098
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.