Identity
- Trade Name
- Pacesaver FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- 3 wheeled scooter FDA UDI
- Model / Reference
- Espree Atlas FDA UDI
- Description
- 3 wheeled scooter FDA UDI
Identifiers
- Catalog Number
- 15035 FDA UDI
- Primary DI / UDI-DI
- B314150351 FDA UDI
- 510(k) Number
- K965123 FDA UDI
- FDA Product Code
- INI FDA UDI
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3800 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: Assistive scooter, electric-motor-driven
Pacesaver by Burke, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive scooter, electric-motor-driven.
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- Legend XL — PRIDE MOBILITY PRODUCTS CORP. · Class II
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- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- Heartway Medical Products Co., Ltd — HEARTWAY MEDICAL PRODUCTS CO., LTD. · Class II
- Vive Mobility — VIVE HEALTH LLC · Class II
- FREERIDER — Freerider Corporation · Class II
- VIVE — VIVE HEALTH LLC · Class II
Cleared under the same submission
K965123 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 II | Pending data |
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Manufacturer
- Manufacturer
- Burke, Inc.
Sources (1)
- FDA UDI aa411b4a-b001-4a95-83cf-0eb02170efbe 36 fields · synced May 30, 2026