FDA UDI
In Commercial Distribution
🇺🇸 United States
WS Far Infrared Therapy Unit
DI: 04719873220199
·
Model: KP-B210
·
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WS Far Infrared Therapy Unit
- Primary DI
- 04719873220199
- Version / Model
- KP-B210
- Company Name
- WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
- Labeler DUNS
- 656915154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-06
- Public Version
- 5
- Public Version Date
- 2020-10-12
- Public Version Status
- Update
- Public Device Record Key
- 3297ccfc-f299-468a-bf14-23a5c9c5d52d
Device Description
The WS Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 μm Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37327 | Full-body radiant heating system | An assembly of mains electricity (AC-powered) devices consisting of an infrared (IR) heating element-containing device designed to emit controlled, evenly distributed heat from above to the full-length of a horizontally-placed adult patient's body requiring a regulated thermal environment and a control unit used to regulate the intensity and the location (full body or specific body region) of heat from the overhead canopy heat source. This device is typically used in, e.g., a burn unit or an intensive care unit (ICU). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719873220199 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160849 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity