FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Low-frequency Stimulator (Model: AST-645, AST-646)
K Number: K212989
·
Decision Nov 22, 2021
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
5
Review Days
63
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Basic Information
- Device Name
- Low-frequency Stimulator (Model: AST-645, AST-646)
- K Number
- K212989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Osto Technology Co., Ltd.
- Date Received
- September 20, 2021
- Decision Date
- November 22, 2021
- 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 Shenzhen Osto Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) | Oct 10, 2019 | Substantially Equivalent |
| K172897 | Neck Care Therapy, Model: SYK 509B | Dec 7, 2018 | Substantially Equivalent |
| K172837 | Low-frequency Multi-function physiotherapy instrument | Nov 26, 2018 | Substantially Equivalent |
| K172834 | Dual output digital therapy massager | Sep 6, 2018 | Substantially Equivalent |