Identity
- Trade Name
- Empulse R90 EUDAMEDEmpulse FDA UDI
- Generic Name
- Wheelchair electric-motor-driven propulsion system FDA UDI
- Device Name
- E-Mobility Device EUDAMEDThe R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. FDA UDI
- Model / Reference
- R90 EUDAMEDFDA UDI
- Description
- The R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair. FDA UDI
Identifiers
- Catalog Number
- EISP8 FDA UDI
- Primary DI / UDI-DI
- 00016958059465 EUDAMEDFDA UDI
- Basic UDI-DI
- 0016958emobilityX7 EUDAMED
- Direct Marketing DI
- 00016958059465 EUDAMED
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Wheelchair electric-motor-driven propulsion system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Empulse R90 by Sunrise Medical (US) LLC — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220213 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0016958emobilityX7 | Class I | Active |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
- EUDAMED SRN
- US-MF-000007254
- Authorised Representative
- Sunrise Medical GmbH DE-AR-000006321
Sources (3)
- EUDAMED ac2f5ef6-af74-499b-8cd0-49edba10c94a 61 fields · synced Jun 18, 2026
- FDA UDI 1a3c3e1e-cf32-490e-b08b-a9498845efca 34 fields · synced May 30, 2026
- FDA 510(k) K220213 1 fields · synced May 18, 2026