FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
K Number: K214037
·
Decision Feb 22, 2024
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
70
Applicant Total
1
Review Days
791
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Basic Information
- Device Name
- Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
- K Number
- K214037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ergo-Flex Technologies, LLC
- Date Received
- December 23, 2021
- Decision Date
- February 22, 2024
- Product Code
- ITH
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| ITH | Equipment, Traction, Powered | FDA class 2 | Physical Medicine |
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