Duns Number:514658082
Device Description: The RecoveryBoot 2-95 NRC-LEG inflatable garment fills and deflates, applying a directiona The RecoveryBoot 2-95 NRC-LEG inflatable garment fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.
Catalog Number
L41R2295H
Brand Name
RecoveryBoot 2-95 NRC-LEG
Version/Model Number
RP-2-95
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060220
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
d8980e52-cbb2-4181-92c2-57ba9ab6fe47
Public Version Date
January 01, 2020
Public Version Number
1
DI Record Publish Date
December 24, 2019
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. | 100 |