Class Class I
Omnispec ED1000 (K210166)
Description
Omnispec ED1000 by Medispec, Ltd., an FDA 510(k) cleared physical medicine device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK210166
Clearance Date2023-01-27
Clearance TypeTraditional
Product CodeISA
Regulation Number890.5660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K210166
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. Omnispec ED1000 (K210166) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021 |
| K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018 |
Trace the full predicate network for K210166
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.