Identity
- Trade Name
- IMAK® Ergo EUDAMEDIMAK Ergo FDA UDI
- Generic Name
- Hot/cold therapy pack, reusable FDA UDI
- Device Name
- IMAK® Ergo HappiNeck - Blue EUDAMEDHappiNeck FDA UDI
- Model / Reference
- A30112 EUDAMEDFDA UDIUniversal EUDAMEDA30111 FDA UDI
- Description
- HappiNeck FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06498333011222 EUDAMED00649833301115 FDA UDI00649833301122 FDA UDI
- Basic UDI-DI
- 649833IMAKKHNBLT9 EUDAMED
- FDA Product Code
- IQK FDA UDI
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
- GMDN Term
- Hot/cold therapy pack, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 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: Hot/cold therapy pack, reusable
IMAK Ergo by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
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- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · 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 (3)
- FDA UDI 42d28278-3c62-43d9-b5a6-1fce4d8fc5e2 33 fields · synced Jul 10, 2026
- FDA UDI ef53014e-51f7-4a34-8cea-27d944259266 33 fields · synced May 30, 2026
- EUDAMED c7468e50-fa30-4efa-9736-a4fcfd56d177 61 fields · synced Jul 10, 2026