Identity
- Trade Name
- Empluse FDA UDI
- Generic Name
- Wheelchair electric-motor-driven propulsion system FDA UDI
- Device Name
- A wheelchair power assist device. It uses a lithium battery to power a single front wheel, which the handlebar can steer. The device is attached to the wheelchair by a hook-and-latched subframe and a permanently installed wheelchair frame clamp. FDA UDI
- Model / Reference
- F35 FDA UDI
- Description
- A wheelchair power assist device. It uses a lithium battery to power a single front wheel, which the handlebar can steer. The device is attached to the wheelchair by a hook-and-latched subframe and a permanently installed wheelchair frame clamp. FDA UDI
Identifiers
- Catalog Number
- EISP11 FDA UDI
- Primary DI / UDI-DI
- 00016958059380 FDA UDI
- 510(k) Number
- K220213 FDA UDI
- FDA Product Code
- ITI FDA UDI
- GMDN Term
- Wheelchair electric-motor-driven propulsion system 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
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
Category: Wheelchair electric-motor-driven propulsion system
Empluse by Sunrise Medical (US) LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wheelchair electric-motor-driven propulsion system.
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- e-fix® — Alber GmbH · Class II
- Batec — BATEC MOBILITY SL. · Class II
- NAVIONE — YAMAHA MOTOR CO., LTD. · Class II
- twion® — Alber GmbH · 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 |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
Sources (1)
- FDA UDI 3e0db3a1-40f6-45fb-be03-751ba438c6e0 35 fields · synced Jun 9, 2026