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PulStar

FDA UDI

Class U (US FDA UDI)

by Sense Technology, Inc.

Identity

Trade Name
PulStar FDA UDI
Generic Name
Joint/spinal manipulator, electronic FDA UDI
Device Name
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. FDA UDI
Model / Reference
G3 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00855341008006 FDA UDI
510(k) Number
K973914 FDA UDI
FDA Product Code
LXM FDA UDI
GMDN Term
Joint/spinal manipulator, electronic FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Joint/spinal manipulator, electronic

PulStar by Sense Technology, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint/spinal manipulator, electronic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sense Technology, Inc.

Sources (1)

  • FDA UDI 9b6ce98f-1321-4f3f-b682-65123163204a 36 fields · synced Jun 1, 2026