Identity
- Trade Name
- Wellell FDA UDI
- Generic Name
- Alternating-pressure bed mattress system FDA UDI
- Device Name
- Procare Bariatric G2 FDA UDI
- Model / Reference
- 9P-087330 FDA UDI
- Description
- Procare Bariatric G2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719893354416 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Alternating-pressure bed mattress system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5550 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alternating-pressure bed mattress system
Wellell by Wellell Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alternating-pressure bed mattress system.
- Vive — VIVE HEALTH LLC · Class II
- PRIUS — Caremed Supply, Inc. · Class II
- PRIUS — Caremed Supply, Inc. · Class II
- Span-America — Span-America Medical Systems, Inc. · Class II
- Pulsate 35 — SIZEWISE RENTALS, L.L.C. · Class I
- FOFO — Foshan Hongfeng Co., Ltd. · Class II
- FOFO — Foshan Hongfeng Co., Ltd. · Class II
- Span-America — Span-America Medical Systems, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wellell Inc.
Sources (1)
- FDA UDI 3f4802f8-e7c2-4224-b64a-20d2a948d86e 33 fields · synced Jun 6, 2026