Identity
- Trade Name
- Karman Healthcare FDA UDI
- Generic Name
- Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible FDA UDI
- Device Name
- XO-101 16" Manual Push-Power Assist Stand Wheelchair FDA UDI
- Model / Reference
- XO-101N FDA UDI
- Description
- XO-101 16" Manual Push-Power Assist Stand Wheelchair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810058400079 FDA UDI
- 510(k) Number
- K122562 FDA UDI
- FDA Product Code
- ITI FDA UDI
- GMDN Term
- Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3860 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, electric-motor-driven, occupant-controlled, powered-steering, 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, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible.
- WHEELCHAIR POWERED — Golden Brothers, Inc · Class II
- Hoveround — Hoveround Corp. · Class II
- Frontier Electric Wheelchair — RED MILAWA PTY. LTD. · Class II
- SHOPRIDER — PIHSIANG MACHINERY MANUFACTURING CO., LTD. · Class II
- iBOT(R) — Mobius Mobility · Class II
- SHOPRIDER — PIHSIANG MACHINERY MANUFACTURING CO., LTD. · Class II
- SHOPRIDER — PIHSIANG MACHINERY MANUFACTURING CO., LTD. · Class II
- Frontier Electric Wheelchair — RED MILAWA PTY. LTD. · Class II
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 63acc28a-5cd2-405e-92ae-ecce179bc82a 34 fields · synced May 30, 2026