FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
K Number: K242567
·
Decision Nov 4, 2024
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
8
Review Days
67
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Basic Information
- Device Name
- Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
- K Number
- K242567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Changsha Anxiang Medical Technology Co., Ltd.
- Date Received
- August 29, 2024
- Decision Date
- November 4, 2024
- Product Code
- NUH
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| 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)
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TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
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TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
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VEINOPLUS Back
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FDA Class 2
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Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
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FDA Class 2
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Other Clearances by Changsha Anxiang Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251429 | OTC 4-Channel Rechargeable TENS Unit | Aug 28, 2025 | Substantially Equivalent |
| K251706 | TENS and EMS Unit | Jul 30, 2025 | Substantially Equivalent |
| K251187 | 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) | Jul 28, 2025 | Substantially Equivalent |
| K250759 | 3 in 1 TENS UNIT | Jun 13, 2025 | Substantially Equivalent |
| K243763 | Wireless TENS & EMS Unit | Mar 12, 2025 | Substantially Equivalent |
| K243511 | OTC TENS & EMS Unit | Feb 10, 2025 | Substantially Equivalent |
| K242787 | Tens & Ems Device (TU1080) | Dec 18, 2024 | Substantially Equivalent |