Duns Number:600300909
Device Description: Orthospec is based on shock wave therapy method and is intended to apply shock waves to th Orthospec is based on shock wave therapy method and is intended to apply shock waves to the heel tissue of patients who have Proximal Plantar Fasciitis and who have failed previous conservative therapies.
Catalog Number
-
Brand Name
Orthospec
Version/Model Number
OR-3-A999u
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
P040026
Product Code
NBN
Product Code Name
Generator, Shock-Wave, For Pain Relief
Public Device Record Key
1ff08c82-3657-4495-9775-aa509907937e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 22, 2017
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. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 1 |