Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4— 510(k) K251856
Substantially EquivalentEveryway Medical Instruments Co.,Ltd
FDA 510(k) clearance K251856 for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4, Substantially Equivalent on 2025-11-21. Applicant: Everyway Medical Instruments Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Everyway Medical Instruments Co.,Ltd
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- New Taipei City, TW
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More clearances from Everyway Medical Instruments Co.,Ltd
view all- K222488 — Everyway Analog OTC TENS
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- K202849 — Everyway Analog OTC TENS, model N103A/N302
- K202470 — Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
- K202317 — Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
Data sourced from openFDA. This site is unofficial and independent of the FDA.