Wireless TENS & EMS (Model SM9110,SM9113,SM9116)— 510(k) K233067
Substantially EquivalentChongqing Rob Linka Science and Technology Co., Ltd.
FDA 510(k) clearance K233067 for Wireless TENS & EMS (Model SM9110,SM9113,SM9116), Substantially Equivalent on 2024-07-19. Applicant: Chongqing Rob Linka Science and Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Chongqing Rob Linka Science and Technology 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
- Chongqing, 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 Chongqing Rob Linka Science and Technology Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.