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Multi Frame
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 9721xxxxxModel SeatingRef 9711xxxxx510(k) K100084
by R82 A/S
Identity
- Trade Name
- Multi Frame EUDAMED
- Model / Reference
- Seating EUDAMED9721xxxxx EUDAMED9711xxxxx EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05707292877338 EUDAMED05707292561787 EUDAMED
- Basic UDI-DI
- 570729212221828 EUDAMED
- 510(k) Number
- K100084 FDA 510(k)
- FDA Product Code
- IOR FDA 510(k)
- EMDN Code
- Y122199 WHEELCHAIRS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDFDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3850 FDA 510(k)
- Regulation Number
- 890.3850 FDA 510(k)
- Market of Registration
- Denmark EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Multi Frame by R82 A/S — Class I — FDA_510K, MDR — listed in EUDAMED, 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 | K100084 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 570729212221828 | Class I | Active |
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Manufacturer
- Manufacturer
- R82 A/S
- EUDAMED SRN
- DK-MF-000000772
Sources (3)
- EUDAMED b1112a98-49d0-4dbb-8d80-c64d3893f03a 61 fields · synced Sep 17, 2026
- EUDAMED ff936c00-1137-4072-beca-87677c636d9e 61 fields · synced May 17, 2026
- FDA 510(k) K100084 24 fields · synced May 18, 2026