Identity
- Trade Name
- Eclipse 350 FDA UDI
- Generic Name
- Push-rim manual wheelchair, bariatric FDA UDI
- Model / Reference
- Eclipse 350 FDA UDI
Identifiers
- Catalog Number
- 99 FDA UDI
- Primary DI / UDI-DI
- B829991 FDA UDI
- 510(k) Number
- K971389 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Push-rim manual wheelchair, bariatric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 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
Yes
FDA UDI
Category: Push-rim manual wheelchair, bariatric
Eclipse 350 by PDG Product Design Group Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K971389 also covers:
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
- PDG Product Design Group Inc
Sources (1)
- FDA UDI 099b3792-ac01-42ae-aadf-0a0f59cb39d2 34 fields · synced May 30, 2026