(233 days)
Not Found
No.
The device description details a system based on controlled tension, servo-motors, and feedback loops for mechanical decompression, without mentioning any AI, ML, or DNN components. While it uses a "treatment computer," its function appears to be control and monitoring based on pre-programmed logic and sensor input, not learning or adaptive intelligence.
Yes
The device is intended to provide a program of treatments for relief from pain for patients suffering with neck pain, specifically by applying spinal decompressive forces to treat conditions such as herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.
No
The device description clearly states that it applies forces to decompress intervertebral spinal disc space and provides treatment for neck pain, not for diagnosing conditions.
No
The device is not a software-only medical device because the description explicitly details numerous hardware components, including a servo-amplifier, servo-motor, load-cell feedback, headpiece harness, patient safety switch, emergency stop button, and mattress, all of which are integral to its function of applying spinal decompressive forces. The software component described (user interface, treatment computer) controls these physical components.
No
The device is a physical therapy system designed for treating neck pain and spinal decompression; it does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The DRX9000C-SL Cervical Spinal Decompression System provides a program of treatments for relief from pain for those patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. Conditions that may be treated include neck pain associated with herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.
Product codes
ITH
Device Description
The DRX9000C-SL Cervical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient.
A headpiece harness is used to help distribute the applied forces evenly. Once in place, the patient is slowly reclined to a horizontal position. Following the physician's orders, the therapist localizes the pain, makes any adjustments and directs the treatment to the proper area. The DRX9000C-SL Cervical Spinal Decompression System helps to mobilize the troubled disc segment without introducing further damage to the spine.
The patient safety switch is held by the patient who at any time and for any reason may quickly pause any tensile forces. The patient safety switch is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.
The emergency stop button is accessible to the operator who at any time and for any reason may quickly pause any tensile forces. The emergency stop button is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.
Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), headpiece harness, patient safety switch, and mattress.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (neck)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare facilities, clinics and / or hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed on the DRX9000C-SL Cervical Spinal Decompression System in order to verify and validate the design and to assure conformance with the following voluntary design standards in connection with electrical safety, electromagnetic compatibility, usability, risk management, biocompatibility and software. Clinical testing is not required for this submission. The non-clinical performance testing described above is sufficient to support substantial equivalence of the subject device to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 18, 2025
Excite Medical of Tampa Bay, LLC
℅ Jon Werner
QA/RA Consultant
Cofactor Technologies, Inc.
2002 Blind Pond Ave
Lutz, Florida 33549
Re: K243366
Trade/Device Name: DRX9000C-SL Cervical Spinal Decompression System
Regulation Number: 21 CFR 890.5900
Regulation Name: Power Traction Equipment
Regulatory Class: Class II
Product Code: ITH
Dated: October 28, 2024
Received: October 28, 2024
Dear Jon Werner:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K243366 - Jon Werner
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K243366 - Jon Werner
Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber T. Ballard -S
Amber Ballard, PhD
Assistant Director
DHT5B: Division of Neuromodulation and Physical Medicine Devices
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243366
Device Name: DRX9000C-SL Cervical Spinal Decompression System
Indications for Use (Describe):
The DRX9000C-SL Cervical Spinal Decompression System provides a program of treatments for relief from pain for those patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. Conditions that may be treated include neck pain associated with herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.
Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Excite Medical of Tampa Bay is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number K243366.
Date Prepared: 9 May 2025
A. SUBMITTER
Excite Medical of Tampa Bay, LLC
4710 Eisenhower Blvd N Suite A-12
Tampa, FL 33634
Establishment Registration Number: 3008816697
Company Contact:
Saleem Musallam
President
Tel: (813) 210-1000
sm@excitemedical.com
B. DEVICE NAME
Proprietary Name: DRX9000C-SL Cervical Spinal Decompression System
Model Numbers:
- DRX9000C-SL Cervical Spinal Decompression System
- DRX9500-SL Bed
- 110-0040 Mechanical Cervical Headpiece Assembly
- 51-0008 Knee Pillow
- 21-0002 – 21-0005 Foam Head Support Sizes 1 – 4
- E-HSC Head Support Cover
Common Name: Equipment, Traction, Powered
Classification Names: Powered Traction Equipment
Regulation Number: 21 CFR Part 890.5900
Classification: Class II
Product Code: ITH
C. PREDICATE / LEGALLY MARKETED DEVICES
Device Name: DRX5000
Company Name: Axiom USA, Inc. (a.k.a. Axiom Worldwide, Inc.)
510(k) #: K023160
Page 1 of 6
Page 6
D. DEVICE DESCRIPTION
The DRX9000C-SL Cervical Spinal Decompression System provides accurately controlled tensions designed to relax and confuse paraspinal muscles and allow distractive forces to decompress intervertebral spinal disc space. The user interface provided by the treatment computer constantly updates a servo-amplifier controlling a servo-motor to immediately and safely apply forces as determined by qualified healthcare personnel. Load-cell feedback is utilized to further verify and adjust tensile forces, allowing for variations in patient posture and outside forces such that continuous and smooth tension is experienced by the patient.
A headpiece harness is used to help distribute the applied forces evenly. Once in place, the patient is slowly reclined to a horizontal position. Following the physician's orders, the therapist localizes the pain, makes any adjustments and directs the treatment to the proper area. The DRX9000C-SL Cervical Spinal Decompression System helps to mobilize the troubled disc segment without introducing further damage to the spine.
The patient safety switch is held by the patient who at any time and for any reason may quickly pause any tensile forces. The patient safety switch is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.
The emergency stop button is accessible to the operator who at any time and for any reason may quickly pause any tensile forces. The emergency stop button is monitored and executed by two redundant systems, which will gradually reduce the tension to zero to stop the treatment and after a 5 second delay directly disable the treatment motor.
Integral to effective spinal decompression and included in the device are continuous load-cell tensile feedback into the treatment computer, servo-amplifier and servo-motor, smoothly modulated cyclic tension application (high and low tension plateaus transitioned into via non-linear tension change), headpiece harness, patient safety switch, and mattress.
E. INTENDED USE / INDICATIONS FOR USE
The DRX9000C-SL Cervical Spinal Decompression System provides a program of treatments for relief from pain for those patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. Conditions that may be treated include neck pain associated with herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.
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Page 7
F. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS
The DRX9000C-SL Cervical Spinal Decompression System indications for use is similar to the predicate device. The technical characteristics and operational parameters of the DRX9000C-SL Cervical Spinal Decompression System are substantially equivalent. The table below shows a comparison of the primary technological characteristics and operational parameters of the DRX9000-SL Cervical Spinal Decompression System to the referenced predicate device.
| Subject Device (K243366) DRX9000C-SL Cervical Spinal Decompression System | Predicate Device (K023160) DRX5000 | |
|---|---|---|
| Intended Use | Prescription use only | Prescription use only |
| Environment | Professional healthcare facilities, clinics and / or hospitals | Professional healthcare facilities, clinics and / or hospitals |
| Indications for Use | The DRX9000C-SL Cervical Spinal Decompression System provides a primary treatment modality for the management of pain for patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome. | The DRX5000 provides a program of treatments for relief from pain for those patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the DRX5000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning. |
| Treatment Areas | Cervical | Cervical / Lumbar |
| Electrical Classification and Type | Class I Type BF | Not publicly available |
| Electrical Safety Consensus Standard | IEC 60601-1:2005 + A1:2012 + A2:2020 | Not publicly available |
| EMC Consensus Standard | IEC 60601-1-2:2014 + A1:2020 | Not publicly available |
| Usability Consensus Standard | IEC 60601-1-6:2010 + A1:2013 + A2:2020 | Not publicly available |
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Page 8
| Subject Device (K243366) DRX9000C-SL Cervical Spinal Decompression System | Predicate Device (K023160) DRX5000 | |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1:2018 and FDA# G95-1 | Not publicly available |
| Traction Mechanism | Electromechanical | Electromechanical |
| Operational Components | Software controlled servo amplifier and servo motor for traction and flexion | Not publicly available |
| Traction Force | Traction limits can be varied between 0 – 50lbs pull | Traction limits can be varied between 0 – 200lbs pull |
| Traction Speed | Continuous, Adjustable | Not publicly available |
| Treatment Time | Up to 30 – 45 minutes | Not publicly available |
| Therapy Mode | Continuous | Not publicly available |
| Power Supply | 100-120VAC / 220-230 VAC, 50/60 Hz | Not publicly available |
| Battery Backup | Yes | Not publicly available |
| Environmental Conditions | Storage / Operation +10 to +40 Celsius 30% to 75% non-condensing 700 to 1060 hPa | Not publicly available |
| Materials | Mattress / Pillow Surfaces: REM114 ADF Remington Headrest Covers: 100% Cotton | Not publicly available |
Page 4 of 6
Page 9
G. SUMMARY OF NON-CLINICAL TESTING
Non-clinical tests were performed on the DRX9000C-SL Cervical Spinal Decompression System in order to verify and validate the design and to assure conformance with the following voluntary design standards in connection with electrical safety, electromagnetic compatibility, usability, risk management, biocompatibility and software.
| Type | Description |
|---|---|
| Electrical safety | • IEC 60601-1:2005 + A1:2012 + A2:2020 [19-49] Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| Electromagnetic compatibility | • IEC 60601-1-2:2014 + A1:2020 [19-36] Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests |
| • IEC TR 60601-4-2:2016 [19-19] Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems | |
| Usability | • IEC 60601-1-6:2010 + A1:2013 + A2:2020 [5-132] Medical electrical equipment – Part 1-6: General requirements for safety and essential performance – Collateral standard: Usability |
| • IEC 62366-1:2015 + A1:2020 [5-129] Medical devices – Part 1: Application of usability engineering to medical devices | |
| Risk management | • ISO 14971:2019 [5-125] Medical devices – Application of risk management to medical devices |
| Biocompatibility | • ISO 10993-1:2018 [5-258] Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |
| Software | • IEC 62304:2006 + A1:2015 [13-79] Medical device software – Software life cycle processes |
H. SUMMARY OF CLINICAL TESTING
Clinical testing is not required for this submission. The non-clinical performance testing described above is sufficient to support substantial equivalence of the subject device to the predicate device.
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Page 10
I. CONCLUSION
The DRX9000C-SL Cervical Spinal Decompression System has a similar intended use, a similar treatment location, the same conditions of use, and the same fundamental scientific technology as the predicate device. The conclusions drawn from the nonclinical performance testing (discussed above) demonstrate that the device raises no new issues of safety or effectiveness and that the DRX9000C-SL Cervical Spinal Decompression System is therefore substantially equivalent to the DRX5000 cleared by K023160.
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