Identity
- Trade Name
- Batec FDA UDI
- Generic Name
- Wheelchair electric-motor-driven propulsion system FDA UDI
- Device Name
- The Handbike Batec Electric is a handcycle mechanism that adapts to a manual wheelchair, forming a three-wheeled chair, allowing the user to move with the help of an electric motor located in the front wheel, optimizing the user's capabilities and increasing their autonomy. FDA UDI
- Model / Reference
- BATEC SCRAMBLER 2 HEMI DER STD - GRAFITO 15 KM/H FDA UDI
- Description
- The Handbike Batec Electric is a handcycle mechanism that adapts to a manual wheelchair, forming a three-wheeled chair, allowing the user to move with the help of an electric motor located in the front wheel, optimizing the user's capabilities and increasing their autonomy. FDA UDI
Identifiers
- Catalog Number
- 25.61.019 FDA UDI
- Primary DI / UDI-DI
- 08436557350220 FDA UDI
- 510(k) Number
- K241159 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
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: Wheelchair electric-motor-driven propulsion system
Batec by Batec Mobility Sl. — 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
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- twion® — Alber GmbH · Class II
- e-fix® — Alber GmbH · Class II
- e-fix® — Alber GmbH · Class II
Cleared under the same submission
K241159 also covers:
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
- Batec — BATEC MOBILITY SL.
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
- Batec Mobility Sl.
Sources (1)
- FDA UDI e47ffe06-4c16-4f0b-9c97-580a43e4d355 35 fields · synced Jun 1, 2026