FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Omnispec ED1000
K Number: K210166
·
Decision Jan 27, 2023
Classifications
1
FEI Numbers
759
Registration Numbers
759
Same Product Code
99
Applicant Total
4
Review Days
736
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Basic Information
- Device Name
- Omnispec ED1000
- K Number
- K210166
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medispec, Ltd.
- Date Received
- January 21, 2021
- Decision Date
- January 27, 2023
- Product Code
- ISA
- 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 |
|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | FDA class 1 | Physical Medicine |
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