I RUNE (I-200L)— 510(k) K122410
Substantially EquivalentMedirune Co, Ltd.
FDA 510(k) clearance K122410 for I RUNE (I-200L), Substantially Equivalent on 2013-11-12. Applicant: Medirune Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Medirune 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
- Gangnam-Gu, KR
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.