FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Lite
K Number: K172409
·
Decision May 2, 2018
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
5
Review Days
266
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Lite
- K Number
- K172409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tzora Active Systems , Ltd.
- Date Received
- August 9, 2017
- Decision Date
- May 2, 2018
- Product Code
- INI
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INI), ordered by most recent decision date.
Virgo Mobility Scooter (Virgo-D,Virgo-F)
FDA 510(k)
FDA Class 2
·Physical Medicine
Scooter (YD-03)
FDA 510(k)
FDA Class 2
·Physical Medicine
Mobility Scooter (Air Carbon)
FDA 510(k)
FDA Class 2
·Physical Medicine
Mobility Scooter (X-12, X-14, X-17)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electrical Scooter (SM4226)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Mobility Scooter (MJMA01, MJMA02)
FDA 510(k)
FDA Class 2
·Physical Medicine