Duns Number:657406062
Device Description: The first wearable, wireless LED light patches for athletes in all sports: on the training The first wearable, wireless LED light patches for athletes in all sports: on the training field, on the road, even at home. CareWear Light Patches start relieving pain and accelerating recovery in just 30 minutes.
Catalog Number
-
Brand Name
CareWear ®
Version/Model Number
CWC-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
665308bb-98e6-4480-a9c5-c50ce9f021c4
Public Version Date
July 29, 2019
Public Version Number
3
DI Record Publish Date
June 26, 2018
Package DI Number
44719872330491
Quantity per Package
4
Contains DI Package
04719872330479
Package Discontinue Date
July 26, 2019
Package Status
Not in Commercial Distribution
Package Type
carry case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |