Duns Number:527128787
Device Description: Bashan TDP Heat Lamp, including TDP-124D/166D and TDP-124F/166F, is an infrared lamp that Bashan TDP Heat Lamp, including TDP-124D/166D and TDP-124F/166F, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help minor muscular back pain.
Catalog Number
-
Brand Name
Bashan
Version/Model Number
TDP-124D,TDP-166D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162590
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
7905ec05-0d0f-4c35-b28f-1f0283eb46e7
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
March 06, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |