Duns Number:783518983
Device Description: • User for: Postural support, Chronic back pain, Lumbar strains or sprains, Post operat • User for: Postural support, Chronic back pain, Lumbar strains or sprains, Post operative rehabilitation, Lumbar instability• The Ultra Support (LSO) Back Brace provides stabilization of the spine and restriction of the pelvis. This, in turn, relieves the pressure on the lumbar discs which helps alleviate pain and increase rehabilitation.• The ergonomic design allows it to be comfortably worn under clothing.• For best fit, download the Sizing Chart below
Catalog Number
1249
Brand Name
Ultra Support Orthopedic Back Brace
Version/Model Number
62301-62305
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
-
Product Code
MRI
Product Code Name
Orthosis, Truncal/Orthosis, Limb
Public Device Record Key
eb7e4364-2bfb-4922-aee1-0982f24476e9
Public Version Date
September 07, 2018
Public Version Number
1
DI Record Publish Date
August 07, 2018
Package DI Number
10891237001246
Quantity per Package
50
Contains DI Package
00891237001249
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |