Identity
- Trade Name
- Pain-x-2000 FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- Infrared Heating Device FDA UDI
- Model / Reference
- Therapy Boot system FDA UDI
- Description
- Infrared Heating Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00865198000306 FDA UDI
- 510(k) Number
- K982546 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blue/red/infrared phototherapy lamp
Pain-x-2000 by Diomedics Light Therapy Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K982546 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diomedics Light Therapy Inc
Sources (1)
- FDA UDI ca2fe674-d979-4e5b-a0ce-7a04d3750a90 35 fields · synced May 30, 2026