FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
K Number: K201845
·
Decision Oct 8, 2020
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
6
Review Days
94
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Basic Information
- Device Name
- Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
- K Number
- K201845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guangzhou Longest Science & Technology Co., Ltd.
- Date Received
- July 6, 2020
- Decision Date
- October 8, 2020
- Product Code
- NGX
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by Guangzhou Longest Science & Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K202110 | MStim Drop Model: LGT-233 | Nov 5, 2021 | Substantially Equivalent |
| K182020 | Portable Electro-Stimulation Therapy Device | Sep 17, 2020 | Substantially Equivalent |
| K191856 | Compression Therapy Device | Mar 19, 2020 | Substantially Equivalent |
| K191862 | Compression Therapy Device Model LGT-2200SP | Oct 29, 2019 | Substantially Equivalent |
| K182108 | Portable Electro-Stimulation Therapy Device | Apr 26, 2019 | Substantially Equivalent |