PulStar
Basic Information
- Brand Name
- PulStar
- Primary DI
- 00855341008006
- Version / Model
- G3
- Company Name
- Sense Technology, Inc.
- Labeler DUNS
- 606184711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-03
- Public Version
- 1
- Public Version Date
- 2023-07-11
- Public Version Status
- New
- Public Device Record Key
- 9b6ce98f-1321-4f3f-b682-65123163204a
Device Description
The PulStar Spine Mobilization Device is intended for use by chiropractors, physical therapists and physicians for mobilization of the spine. The device consists of a hand-held impulse head attached to an electronic control module. The control module is connected to an Apple computer through a USB cable. Appropriate software is used to display the results of tissue compliance measurements. Intended Use and operation: Intended use of the PulStar is for the treatment of musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm and ligamentous strain. The clinician uses a hand held impulse head to test the stiffness of the patient’s spine at each vertebral level, the results of this procedure are recorded in the patient file in a computer database and displayed on the computer screen. The clinician then decides where therapy is needed and applies multiple impulses with the impulse head to those areas of the body of the patient with the intent of reducing spinal stiffness. After treatment, the clinician repeats the initial test of the patient’s spine to document changes in stiffness effected by the therapy.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LXM | Manipulator, Plunger-Like Joint | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58785 | Joint/spinal manipulator, electronic | A hand-held, electrically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. The electromechanical instrument is typically pistol-like in shape and uses a plunger-like mechanism to deliver thrust to the patient's body with a single or double rubber-tipped stylus; it typically has several force settings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10855341008003 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00855341008006 | GS1 |
Customer Contacts
- Phone
- 800 628 9416
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973914 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal