FDA UDI
In Commercial Distribution
🇺🇸 United States
Inspirstar
DI: B524IS02BA0
·
Model: IS02BA
·
INSPIRSTAR INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Inspirstar
- Primary DI
- B524IS02BA0
- Version / Model
- IS02BA
- Company Name
- INSPIRSTAR INC
- Labeler DUNS
- 783216174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-21
- Public Version
- 8
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- a11d6e10-c039-49bf-83db-9596500b9776
Device Description
Inspirstar IS02BA 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B524IS02BA0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060368 | 000 |