SM Electrodes— 510(k) K183154
Substantially EquivalentHong Qiangxing (Shenzhen) Electronics Limited
FDA 510(k) clearance K183154 for SM Electrodes, Substantially Equivalent on 2019-03-26. Applicant: Hong Qiangxing (Shenzhen) Electronics Limited. Device class: 2.
Clearance details
- Applicant
- Hong Qiangxing (Shenzhen) Electronics Limited
- Product code
- Product code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
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More clearances from Hong Qiangxing (Shenzhen) Electronics Limited
view all- K261574 — Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
- K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
- K220283 — TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
- K220152 — TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
- K220150 — TENS & PMS (Model: SM9126)
Data sourced from openFDA. This site is unofficial and independent of the FDA.