Duns Number:783216174
Device Description: Inspirstar IS02BAs is a high-end precision medical instrument used for the relief of pain. Inspirstar IS02BAs is a high-end precision medical instrument used for the relief of pain. This product can generate low intensity current pulses at microampere level (up to 400 microampere) and frequency of pulses (up to 1000Hz). This product have five therapy programs. Each program includes multiple sub-programs. There are five keys on the device for each program. No screen.
Catalog Number
-
Brand Name
Inspirstar
Version/Model Number
IS02BAs
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K060368
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
8d56b534-997f-4d2f-b3d5-9f475254bc6c
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
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. | 6 |