FDA 510(k)
FDA class 2
Substantially Equivalent
🇭🇰 Hong Kong
Tyece OTC EMS System
K Number: K183454
·
Decision Feb 26, 2019
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
3
Review Days
75
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Basic Information
- Device Name
- Tyece OTC EMS System
- K Number
- K183454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tyece , Ltd.
- Date Received
- December 13, 2018
- Decision Date
- February 26, 2019
- 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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