Identity
- Trade Name
- Probasics FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- K4 Deluxe Anti-Tippers FDA UDI
- Model / Reference
- X1WC4DAM04 FDA UDI
- Description
- K4 Deluxe Anti-Tippers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815067013104 FDA UDI
- FDA Product Code
- IMR FDA UDI
- GMDN Term
- Push-rim manual wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3920 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Push-rim manual wheelchair, non-bariatric
Probasics by Compass Health Brands Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Push-rim manual wheelchair, non-bariatric.
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- RoughRider — ROUGHRIDER AMERICA LLC · Class I
- JUDITTA — ORMESA SRL · Class I
- R82 — R82 A/S · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 76237003-0fcc-4e28-b5ba-8c5b21e98bbf 34 fields · synced May 31, 2026