Class Class II
TENS & EMS Stimulator (MHD-1083) (K241678)
Description
TENS & EMS Stimulator (MHD-1083) by Shenzhen Minghuangda Electronics Co., Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241678
Clearance Date2024-09-09
Clearance TypeTraditional
Product CodeNUH
Regulation Number882.5890
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241678
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. TENS & EMS Stimulator (MHD-1083) (K241678) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K190115 | MHD TENS | Minghuangda Electronic Co., Ltd. | 2019 |
| K133929 | HEALTH EXPERT ELCTRONIC STIMULATOR | Shenzhen Osto Technology Company Li... | 2014 |
Trace the full predicate network for K241678
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.