Identity
- Trade Name
- Merits FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Ultra P325 Base FDA UDI
- Model / Reference
- P325 30200815 FDA UDI
- Description
- Ultra P325 Base FDA UDI
Identifiers
- Catalog Number
- P325 30200815 FDA UDI
- Primary DI / UDI-DI
- 00835246004570 FDA UDI
- 510(k) Number
- K113577 FDA UDI
- FDA Product Code
- ITI FDA UDI
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled 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
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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: Electric-motor-driven wheelchair, occupant-controlled
Merits by Merits Health Products., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electric-motor-driven wheelchair, occupant-controlled.
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- WHILL, Inc. — WHILL, INC. · Class II
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- MODULAR POWER POSITIONING SYSTEM — Motion Concepts Inc · Class II
- XSTO — XSTO CO., LTD. · Class II
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- Drive — Drive Devilbiss Healthcare · Class I
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Cleared under the same submission
K113577 also covers:
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., INC.
- MERITS — MERITS HEALTH PRODUCTS., 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
- Merits Health Products., Inc.
Sources (1)
- FDA UDI a00adae9-ded8-453d-a909-98118d28d9cc 35 fields · synced Jun 1, 2026