FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Little Wave Arc; Little Wave Flip
K Number: K223533
·
Decision Aug 31, 2023
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
7
Applicant Total
5
Review Days
281
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
- Little Wave Arc; Little Wave Flip
- K Number
- K223533
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ki Mobility, LLC
- Date Received
- November 23, 2022
- Decision Date
- August 31, 2023
- Product Code
- LBE
- 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 |
|---|---|---|---|
| LBE | Stroller, Adaptive | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBE), ordered by most recent decision date.
PEDIATRIC FOLDING WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
SULKY SPECIAL
FDA 510(k)
FDA Class 1
·Physical Medicine
PERAMBULATOR (STROLLER)
FDA 510(k)
FDA Class 1
·Physical Medicine
CARRIER
FDA 510(k)
FDA Class 1
·Physical Medicine
MECHANICAL CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CONVAID CRUISER CP4M
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Ki Mobility, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K201869 | Ki Power Tilt System | Sep 5, 2023 | Substantially Equivalent |
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Sep 5, 2023 | Substantially Equivalent |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Aug 31, 2023 | Substantially Equivalent |
| K062660 | CATALYSY | Oct 24, 2006 | Substantially Equivalent |