FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
StimPlus Patch, StimPlus Patch, StimPlus Patch
K Number: K200561
·
Decision Jul 1, 2020
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
10
Review Days
119
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Basic Information
- Device Name
- StimPlus Patch, StimPlus Patch, StimPlus Patch
- K Number
- K200561
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jkh Health Co., Ltd.
- Date Received
- March 4, 2020
- Decision Date
- July 1, 2020
- 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 |
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Other Clearances by Jkh Health Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253150 | Cryon-X Cold Compression | Oct 24, 2025 | Substantially Equivalent |
| K240788 | Ultrasound Stimulator | Jun 4, 2025 | Substantially Equivalent |
| K240986 | Cold Compression | May 1, 2024 | Substantially Equivalent |
| K240011 | Lymphedema Compression | Feb 23, 2024 | Substantially Equivalent |
| K223541 | Cold/Hot Compression | Oct 27, 2023 | Substantially Equivalent |
| K211050 | Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 | Nov 28, 2022 | Substantially Equivalent |
| K202839 | Overlapped Compression Therapy | Jan 21, 2021 | Substantially Equivalent |
| K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Apr 14, 2017 | Substantially Equivalent |
| K153520 | Electronic Pulse Stimulator | May 5, 2016 | Substantially Equivalent |