SmartTENS— 510(k) K143430
Substantially EquivalentEasy Med Instrument Co., Ltd.
FDA 510(k) clearance K143430 for SmartTENS, Substantially Equivalent on 2015-05-29. Applicant: Easy Med Instrument Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Easy Med Instrument 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
- Abbreviated
- Location
- Daliang, Shunde, Foshan, Guang Dong, 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 Easy Med Instrument Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.