Duns Number:342585299
Device Description: Indications for UseThe OrthoGold100® is intended for :• Relief of minor muscle aches and p Indications for UseThe OrthoGold100® is intended for :• Relief of minor muscle aches and pains• Temporary increase in local blood circulation• Activation of connective tissue
Catalog Number
1000013
Brand Name
OrthoGold100®
Version/Model Number
OW100-US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
b0fd3628-c2a6-4874-8ad3-6e035459b137
Public Version Date
June 14, 2021
Public Version Number
4
DI Record Publish Date
January 23, 2019
Package DI Number
04260484571618
Quantity per Package
1
Contains DI Package
04260484571601
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |