FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
SM TENS & PMS
K Number: K121719
·
Decision May 10, 2013
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
9
Review Days
333
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Basic Information
- Device Name
- SM TENS & PMS
- K Number
- K121719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hong Qiangxing (Shenzhen) Electronics Limited
- Date Received
- June 11, 2012
- Decision Date
- May 10, 2013
- Product Code
- NGX
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by Hong Qiangxing (Shenzhen) Electronics Limited
| K Number | Device Name | ||
|---|---|---|---|
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Dec 23, 2025 | Substantially Equivalent |
| 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 |