Identity
- Trade Name
- Karman Healthcare FDA UDI
- Generic Name
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible FDA UDI
- Device Name
- XO-55 Horizon series 18" Seat Manual Propel Manual Stand FDA UDI
- Model / Reference
- XO-55 FDA UDI
- Description
- XO-55 Horizon series 18" Seat Manual Propel Manual Stand FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810058400031 FDA UDI
- 510(k) Number
- K122562 FDA UDI
- FDA Product Code
- IPL FDA UDI
- GMDN Term
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Category: Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible
Karman Healthcare by Karman Healthcare Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible.
- Everest & Jennings — GF Health Products, Inc · Class I
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- Stellar LEAP Manual Tilt Wheelchair — PDG Product Design Group Inc · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
- Motion composites — Motion Composites · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
- Fuze Manual Tilt Wheelchair — PDG Product Design Group Inc · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
Cleared under the same submission
K122562 also covers:
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Healthcare — KARMAN HEALTHCARE INC.
- Karman Heatlhcare — KARMAN HEALTHCARE INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Karman Healthcare Inc.
Sources (1)
- FDA UDI 95b7087e-9d0f-40b8-ba42-8e15605a3c7b 34 fields · synced May 30, 2026