Duns Number:002692106
Device Description: LED Light Therapy. Uses 1820 LED. Purpose is to relieve minor joint or muscle pain using I LED Light Therapy. Uses 1820 LED. Purpose is to relieve minor joint or muscle pain using Infrared Light or Combo Red/Infrared Light to provide a feeling of General Wellness.
Catalog Number
-
Brand Name
POLY Pro
Version/Model Number
Regen
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
-
Product Code
PWC
Product Code Name
General Wellness Product
Public Device Record Key
27615d19-b32b-405f-8137-acb40af9bbbf
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
October 31, 2018
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. | 21 |
| U | Unclassified | 3 |