Identity
- Trade Name
- Freedom Designs Freedom 2 Series Manual Wheelchair FDA UDI
- Generic Name
- Attendant-only-propelled wheelchair, non-bariatric FDA UDI
- Device Name
- Lightweight Manual Folding Wheelchair FDA UDI
- Model / Reference
- FD2_SERIES FDA UDI
- Description
- Lightweight Manual Folding Wheelchair FDA UDI
Identifiers
- Catalog Number
- FD2-30270XX, FD2K-3027XX FDA UDI
- Primary DI / UDI-DI
- 00841447101376 FDA UDI
- 510(k) Number
- K983763 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Attendant-only-propelled wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Commercial Distribution
- Not 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
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
Freedom Designs Freedom 2 Series Manual Wheelchair by Invacare Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Invacare Corp.
Sources (1)
- FDA UDI 84347e89-4d3a-41d4-8713-1768564188ce 37 fields · synced Jun 8, 2026