LL TENS 160A, LL TENS 160B— 510(k) K152374
Substantially EquivalentFuji Dynamics , Ltd.
FDA 510(k) clearance K152374 for LL TENS 160A, LL TENS 160B, Substantially Equivalent on 2016-01-13. Applicant: Fuji Dynamics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Fuji Dynamics , 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
- Hong Kong, 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 Fuji Dynamics , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.