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Little Wave Flip
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref FLIP XPModel Manual Wheelchairs
Identity
- Trade Name
- LITTLE WAVE FLIP EUDAMEDFDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- LITTLE WAVE FLIP MANUAL WHEELCHAIR FDA UDI
- Model / Reference
- Manual Wheelchairs EUDAMEDFLIP XP EUDAMEDFLIP FDA UDI
- Description
- LITTLE WAVE FLIP MANUAL WHEELCHAIR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013379132 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850013379MANUALWN EUDAMED
- 510(k) Number
- K223533 FDA UDI
- FDA Product Code
- LBE FDA UDI
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
- GMDN Term
- Push-rim manual wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Push-rim manual wheelchair, non-bariatric
Little Wave Flip by Ki Mobility, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Push-rim manual wheelchair, non-bariatric.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Probasics — COMPASS HEALTH BRANDS CORP. · Class I
- DALTON WIDE MANUAL WHEELCHAIR — Dalton Medical Corp. · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Probasics — COMPASS HEALTH BRANDS CORP. · Class I
- RoughRider — ROUGHRIDER AMERICA LLC · Class I
- JUDITTA — ORMESA SRL · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ki Mobility, Llc
Sources (2)
- FDA UDI b1b053e0-c2ce-47d2-9504-f687befea924 35 fields · synced Jul 28, 2026
- EUDAMED 841d24c7-5415-47b0-b146-d627a7120eb1 61 fields · synced Jul 28, 2026