PulStar

Primary DI
10855341008003
Brand
PulStar
Company
Sense Technology, Inc.
Model
G3
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.
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXMManipulator, Plunger-Like Joint

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXMManipulator, Plunger-Like JointUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973914000SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTARSense Technology, Inc.1998-06-30LXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855341008003PackageGS11In Commercial Distribution
00855341008006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085534100800310855341008003
00855341008006008553410080068553410080060855341008006

GMDN Terms#

Term, Definition table
TermDefinition
Joint/spinal manipulator, electronicA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800 628 9416info@pulstar.us

Regulatory Flags#

DUNS number
606184711
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855341008006PulStarG32023-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00860011416418Impulse iQ Adjusting InstrumentNeuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416463Prosports 360Neuromechanical Innovations, L.L.C.LXM2024-01-13
00860011416470ProAdjuster SRTNeuromechanical Innovations, L.L.C.LXM2024-01-13
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