Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806— 510(k) K202317
Substantially EquivalentEveryway Medical Instruments Co.,Ltd
FDA 510(k) clearance K202317 for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806, Substantially Equivalent on 2020-11-13. 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
- Traditional
- Location
- Shenkeng District, New Taipei City, CN
Recent devices under product code NUH
view all- K261131 — Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J +6 more
- K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
- K253896 — TENS/EMS device (GUSE01)
- K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
More clearances from Everyway Medical Instruments Co.,Ltd
view allData sourced from openFDA. This site is unofficial and independent of the FDA.