FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K Number: K253740
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
9
Review Days
29
Basic Information
- Device Name
- TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
- K Number
- K253740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hong Qiangxing (Shenzhen) Electronics Limited
- Date Received
- November 24, 2025
- Decision Date
- December 23, 2025
- Product Code
- NUH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
FDA 510(k)
FDA Class 2
·Neurology
TENS/EMS device (GUSE01)
FDA 510(k)
FDA Class 2
·Neurology
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
FDA 510(k)
FDA Class 2
·Neurology
VEINOPLUS Back
FDA 510(k)
FDA Class 2
·Neurology
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
FDA 510(k)
FDA Class 2
·Neurology
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Hong Qiangxing (Shenzhen) Electronics Limited
| K Number | Device Name | ||
|---|---|---|---|
| K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) | May 2, 2022 | Substantially Equivalent |
| K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) | Apr 19, 2022 | Substantially Equivalent |
| K220150 | TENS & PMS (Model: SM9126) | Feb 17, 2022 | Substantially Equivalent |
| K201354 | TENS & PMS | Dec 11, 2020 | Substantially Equivalent |
| K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | Dec 2, 2019 | Substantially Equivalent |
| K183154 | SM Electrodes | Mar 26, 2019 | Substantially Equivalent |
| K133108 | FIT BELT | Aug 5, 2014 | Substantially Equivalent |
| K121719 | SM TENS & PMS | May 10, 2013 | Substantially Equivalent |