FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Next Generation iBOT
K Number: K172601
·
Decision Mar 2, 2018
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
10
Review Days
184
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Basic Information
- Device Name
- Next Generation iBOT
- K Number
- K172601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3890
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deka Research & Development Corp.
- Date Received
- August 30, 2017
- Decision Date
- March 2, 2018
- Product Code
- IMK
- 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 |
|---|---|---|---|
| IMK | Wheelchair, Stair Climbing | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IMK), ordered by most recent decision date.
iBOT® PMD
FDA 510(k)
FDA Class 2
·Physical Medicine
iBOT Personal Mobility Device (iBOT PMD)
FDA 510(k)
FDA Class 2
·Physical Medicine
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