FDA UDI
In Commercial Distribution
🇺🇸 United States
JAS Pulse 3MHz
DI: 00861681000310
·
Model: 64-405-0005
·
AXIOSONIC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JAS Pulse 3MHz
- Primary DI
- 00861681000310
- Version / Model
- 64-405-0005
- Company Name
- AXIOSONIC, LLC
- Labeler DUNS
- 080247643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-05
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 4d90ed5a-461a-4f70-a80c-57db876a2fa5
Device Description
A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.
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
- No
- 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 |
|---|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11248 | Physical therapy ultrasound system | An assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861681000310 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161628 | 000 |