Identity
- Trade Name
- Kinetic Elbow Sleeve EUDAMEDSpark FDA UDI
- Generic Name
- Elbow joint orthosis component FDA UDI
- Device Name
- Spark® Kinetic Elbow Sleeve EUDAMEDSpark Kinetic Elbow FDA UDI
- Model / Reference
- 40417 EUDAMEDFDA UDIMedium EUDAMED
- Description
- Spark Kinetic Elbow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821614041704 EUDAMED00082161404170 FDA UDI
- Basic UDI-DI
- 082161SPARKKESMD40HN EUDAMED
- FDA Product Code
- IOY FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Elbow joint orthosis component FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Elbow joint orthosis component
Spark by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
Sources (2)
- FDA UDI 89fd0354-487f-4b1e-837a-69d7130928bf 33 fields · synced Jul 21, 2026
- EUDAMED b6014284-c862-4cac-8de3-b834040245b2 61 fields · synced Jul 21, 2026