Identity
- Trade Name
- Kinetic Calf Sleeve EUDAMEDSpark FDA UDI
- Generic Name
- Hip/knee orthosis FDA UDI
- Device Name
- Spark® Kinetic Calf Sleeve EUDAMEDSpark Kinetic Calf FDA UDI
- Model / Reference
- 40422 EUDAMEDFDA UDILarge EUDAMED
- Description
- Spark Kinetic Calf FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821614042244 EUDAMED00082161404224 FDA UDI
- Basic UDI-DI
- 082161SPARKKCSLG63 EUDAMED
- FDA Product Code
- ISY FDA UDI
- EMDN Code
- M0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Hip/knee orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 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: Hip/knee orthosis
Spark by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hip/knee orthosis.
- Vive — VIVE HEALTH LLC · Class I
- VIVE — VIVE HEALTH LLC · Class I
- Spark — BROWNMED, INC. · Class I
- Spark — BROWNMED, INC. · Class I
- IMAK Compression — BROWNMED, INC. · Class I
- Spark — BROWNMED, INC. · Class I
- IMAK Compression — BROWNMED, INC. · Class I
- Spark — BROWNMED, INC. · Class I
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 58198c56-a57f-4e53-9880-2402df34a1ee 33 fields · synced Jun 20, 2026
- EUDAMED 7803591e-bfa1-422d-9dfa-23a758ceec4e 61 fields · synced Jun 20, 2026