TENS and EMS Stimulation (OTC)— 510(k) K212184
Substantially EquivalentChangsha Yuwen Medical Equipment Co., Ltd.
FDA 510(k) clearance K212184 for TENS and EMS Stimulation (OTC), Substantially Equivalent on 2022-04-01. Applicant: Changsha Yuwen Medical Equipment Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Changsha Yuwen Medical Equipment Co., Ltd.
- Product code
- Product 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
- Changsha, 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 Changsha Yuwen Medical Equipment Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.