← Back to catalogue
Polar Care Wave Intl
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 100716-000Model DOC 1000-02 POLAR CARE WAVE
by Breg, Inc.
Identity
- Trade Name
- POLAR CARE WAVE INTL EUDAMEDBREG FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Model / Reference
- DOC 1000-02 POLAR CARE WAVE EUDAMED100716-000 EUDAMEDPOLAR CARE WAVE INTL FDA UDI
Identifiers
- Catalog Number
- 100716-000 FDA UDI
- Primary DI / UDI-DI
- 00672736140987 EUDAMEDFDA UDI
- Basic UDI-DI
- 0672736000618R EUDAMED
- 510(k) Number
- K183702 FDA UDI
- FDA Product Code
- IRP FDA UDI
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5650 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Polar Care Wave Intl by Breg, Inc. — Class IIa — 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 | K183702 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0672736000618R | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Breg, Inc.
- EUDAMED SRN
- US-MF-000018362
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 4a72c519-61e3-4f7e-bd03-23cfe4ce2504 61 fields · synced Aug 2, 2026
- FDA UDI 561431bc-75e3-436e-9f8a-5b9fe4b53aca 34 fields · synced May 30, 2026
- FDA 510(k) K183702 1 fields · synced May 18, 2026