FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
TENS/EMS device (GUSE01)
K Number: K253896
·
Decision Mar 4, 2026
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
5
Review Days
89
Basic Information
- Device Name
- TENS/EMS device (GUSE01)
- K Number
- K253896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globalcare Medical Technology Co., Ltd.
- Date Received
- December 5, 2025
- Decision Date
- March 4, 2026
- Product Code
- NUH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
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 AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
FDA 510(k)
FDA Class 2
·Neurology
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
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 Globalcare Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | Apr 8, 2025 | Substantially Equivalent |
| K222160 | GUS610 Blood pressure monitor | Nov 22, 2022 | Substantially Equivalent |
| K192633 | GUS831 Compressor Nebulizer | May 1, 2020 | Substantially Equivalent |
| K192609 | Globalcare Blood Pressure Monitor | Apr 21, 2020 | Substantially Equivalent |