Modpod

K150695 · Hollywog, LLC · ITH · Aug 13, 2015 · Physical Medicine

Device Facts

• Record ID: K150695
• Device Name: Modpod
• Applicant: Hollywog, LLC
• Product Code: ITH · Physical Medicine
• Decision Date: Aug 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Modpod cervical traction provides mobilization of skeletal structures and muscles in static, intermittent, progressive, and regressive distraction forces to relieve pressures that may be causing pain of skeletal or muscular origin. These effects are achieved through decompression of intervertebral discs, that is, unloading due to distraction and positioning, and may be used to relieve peripheral radiation/sciatica and pain associated with: Protruding discs Bulging discs Herniated discs Degenerative disc disease Posterior facet syndrome Acute facet problems Radicular pain Prolapsed discs Spinal root impingement Hypomobility Degenerative joint disease Facet syndrome Compressions fracture Joint pain Discogenic pain

Device Story

Modpod is a cervical traction device for outpatient clinical use. It applies static, intermittent, progressive, and regressive distraction forces to the cervical spine to decompress intervertebral discs and relieve pain. A clinician operates the device via a touch display screen, selecting programmable traction patterns. The device uses an electromechanical linear actuator with a brush-type DC motor to apply force, monitored by an internal load cell. The clinician remains present to supervise the patient. The device includes a patient-held stop switch for safety. Output is the physical distraction of the cervical spine. Benefits include reduced clinician exertion compared to manual traction and precise, automated force maintenance if the patient shifts. The device is battery-powered with an automatic charging system.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included verification of traction force delivery, battery charging/monitoring, noise levels (26-56dB), and compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.

Technological Characteristics

Materials: ABS plastic, painted sheet metal, I-Skin Polyurethane cushions. Actuation: Electromechanical linear actuator with brush-type DC motor. Energy: 12VDC from rechargeable lithium-ion battery (3200mAh), charged via 100-240VAC mains. Connectivity: Standalone. Sterilization: Non-sterile. Software: Embedded control for actuator and user interface. Standards: IEC 60601-1:2005 Ed.3, IEC 60601-1-2:2007 Ed.3.

Indications for Use

Indicated for adults of all ages requiring cervical traction for pain relief associated with disc-related conditions (protruding, bulging, herniated, prolapsed, degenerative), facet syndromes, radicular pain, spinal root impingement, hypomobility, and joint pain. Contraindicated for patients unable to tolerate supine positions.

Regulatory Classification

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.

Predicate Devices

• Triton/Tru-Trac/TX Traction (K051938)
• Triton/Tru-Trac/TX Traction (K053223)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Auqust 13, 2015

Hollywog, LLC Michael Treas Chief Compliance Officer 2830 Ammicola Highway Chattanooga, Tennessee 37377

Re: K150695

Trade/Device Name: Modpod Regulation Number: 21 CFR 890.5900 Regulation Name: Power Traction Equipment Regulatory Class: Class II Product Code: ITH Dated: July 9, 2015 Received: July 10, 2015

Dear Mr. Treas:

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 (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. 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -SFD/^

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K150695

Device Name Modpod

#### Indications for Use (Describe)

Modpod cervical traction provides mobilization of skeletal structures and muscles in static, intermittent, progressive, and regressive distraction forces to relieve pressures that may be causing pain of skeletal or muscular origin. These effects are achieved through decompression of intervertebral discs, that is, unloading due to distraction and positioning, and may be used to relieve peripheral radiation/sciatica and pain associated with:

·Protruding discs

·Bulging discs

- ·Herniated discs
·Degenerative disc disease

·Posterior facet syndrome

· Acute facet problems

•Radicular pain

·Prolapsed discs

- ·Spinal root impingement
·Hypomobility

·Degenerative joint disease

·Facet syndrome

·Compressions fracture

•Joint pain

· Discogenic pain

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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ES

A leap forward™

Holluwoa 830 Amnicola Highway nattanooga, TN 37406 USA [phone] [phone] holluwoa.com

# 510(k) Summary per 21 CFR; 807.92 510(k) K150695

| 510(k) SUBMITTER: | Hollywog, LLC |
|-----------------------------|----------------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION: | 3008585473 |
| CONTACT: | Michael W. Treas<br>Chief Compliance Officer<br><br>Telephone [phone]<br>Fax [phone] |
| DATE PREPARED: | July 9, 2015 |
| PROPRIETARY NAME: | ModpodTM |
| PANEL: | Physical Medicine |
| REGULATION NUMBER: | CFR Title 21, 890.5900 |
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | ITH |
| REGULATION DESCRIPTION: | Power traction equipment |
| COMMON NAME: | Cervical traction |

The Modpod™ Cervical Traction Device provides static and intermittent distraction forces to the cervical spine to relieve pressures on structures that may be causing pain of skeletal or muscular origin. Therapeutic distraction can be applied in a variety of programmable patterns and functions.

The device design allows a clinician access to a patients head and neck when hands-on interaction and positioning is needed. Use of the device reduces the level of exertion experienced by the clinician when compared to manual traction therapy techniques. Additionally, hands-on interaction and positioning by the clinician may occur before or after treatment.

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| 510(k) # | Predicate Proprietary Trade Name | Predicate Regulation |
|----------|----------------------------------|--------------------------------------------|
| K051938 | Triton®/Tru-Trac®/TX™ Traction | CFR Title 21, Sec. 890.5900, Class II, ITH |
| K053223 | Triton®/Tru-Trac®/TX™ Traction | CFR Title 21, Sec. 890.5900, Class II, ITH |

Legally marketed devices to which substantial equivalence is claimed:

The indications for use are substantially equivalent to the claimed predicate devices. Differences between indications for use do not affect safety or effectiveness when used as labeled and as intended. The intended patient population is adults of all ages.

The power supply is an off-the-shelf wall plug type that complies with the IEC 60601-1:2005 Ed.3 standard. The power supply steps down mains voltage to 12VDC and solely serves to charge the lithium ion batteries. The device operates exclusively from the batteries whether the power supply/battery charger is used or not used. The power supply/battery charger automatically switches 100-240VAC +/- 10%; 47-63Hz; 1 Phase; Current 0.9A @ 100VAC to accommodate most electric power service systems worldwide.

If the device is plugged into mains power and not in use the battery is constantly trickle charged. If the device is being used while plugged into mains power the electronic design allows any unused energy from mains power to charge the batteries. The device uses a charging IC to control and regulate charging of the batteries to ensure the batteries do not overcharge. If the device is operating solely on battery power (not plugged into mains power) no charging occurs. The battery voltage is monitored and the battery life status is displayed on the screen. Once the voltage is discharged to near the minimum voltage needed to run the charging IC; the device display screen shows an error and uses an audible tone to alert the clinician the battery needs to be plugged into mains power for charging.

A clinician interfaces with the device through a touch display screen. The electronics and software control the actuator. The device includes an electronic load cell calibrated during the manufacturing process. Subsequent calibration is not be required because the electronics tare/set the load cell to zero each time the device is turned on. Traction forces are administered by an electromechanical linear actuator with a brush-type DC motor. The device is intended for therapeutic care on an outpatient basis. Monitoring technology maintains the set traction force if a patient were to shift or move during a treatment. The actuator has the capability to operate at 12 Volts; the design requires only 4 volts to achieve the desired speed and to lessen the operating noise level. The design uses plastic gears in the actuator to reduce noise. There is no additional voltage generated above that of the batteries, and no components are operated outside their specified ratings. Additionally, the actuator has an internal encasement plus the device encases the actuator. Therefore, the plastic actuator gears are double encased for a high degree of noise reduction. Sound measured during operation of the device measured in the proximity of a patient's ear ranged from 26db to 56db when the actuator is in operation; to virtually no observable sound when the actuator reaches the treatment set point.

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The treatment should only be administered under the presence of a doctor or therapist. The doctor or therapist should be present at all times and supervise the treatment carefully. Never leave the patient alone during the treatment. Use care on patients who do not tolerate supine positions, as they may not be good candidates for traction therapy. There are two types of head harnesses. One head harness has a chin strap; the other does not have a chin strap. The head harness without a chin strap may be chosen by a clinician for their patients who experience discomfort related to pressure sensitivity related to Temporomandibular joint dysfunction (TMJ).

The head halter comes in Cotton Duct Fabric and PVC Coated Polyester Fabric both with Velcro@ adjustment for ease of patient setup in the device cushions are made of I-Skin Polyurethane. The cushion set consists of a Shoulder Support Cushion and Head Support Cushions in 10°, 15° and 20°.

## Conclusion:

The Modpod cervical traction device is as safe and effective, and performs as well or better than the claimed predicate devices.

Technical Comparison Attached -

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| 510(k) | K150695 | K051938 | K053223 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 890.5900 | 890.5900 | 890.5900 |
| Product Class | Class II | Class II | Class II |
| Product Code | ITH | ITH | ITH |
| Intended environment of use | Outpatient clinic | Outpatient clinic | Outpatient clinic |
| Indications for use | Indications for use<br>Modpod cervical traction provides mobilization of skeletal<br>structures and muscles in static, intermittent, progressive, and<br>regressive distraction forces to relieve pressures that may be<br>causing pain of skeletal or muscular origin. These effects are<br>achieved through decompression of intervertebral discs, that is,<br>unloading due to distraction and positioning, and may be used<br>to relieve peripheral radiation/sciatica and pain associated<br>with:<br>• Protruding discs<br>• Bulging discs<br>• Herniated discs<br>• Degenerative disc disease<br>• Posterior facet syndrome<br>• Acute facet problems<br>• Radicular pain<br>• Prolapsed discs<br>• Spinal root impingement<br>• Hypomobility<br>• Degenerative joint disease<br>• Facet syndrome<br>• Compressions fracture<br>• Joint pain<br>• Discogenic pain | Indications for use<br>The Triton/Tru-Trac/TX traction devices provide traction and<br>mobilization of skeletal structures and skeletal muscles.<br>The Triton/Tru-Trac/TX traction devices provide a treatment<br>in static, intermittent, progressive, regressive and cycling<br>distraction forces to relieve pressures on structures that may be<br>causing pain of skeletal or muscular origin (cervical, thoracic,<br>lumbar, hip, wrist, shoulder). Therapeutic distraction can be<br>applied in a variety of programmable<br>patterns, cycles and functions.<br>The Triton/Tru-Trac/TX traction devices may be used to<br>relieve peripheral radiation/sciatica and pain associated with:<br>• Protruding discs<br>• Bulging discs<br>• Herniated discs<br>• Degenerative disc disease<br>• Posterior facet syndrome<br>• Acute facet problems<br>• Radicular pain<br>• Prolapsed discs<br>• Spinal root impingement<br>• Hypomobility<br>• Degenerative joint disease<br>• Facet syndrome<br>• Compressions fractures<br>• Joint pain<br>• Discogenic pain<br>The Triton/Tru-Trac/TX traction devices achieve these effects<br>through decompression of<br>intervertebral discs, that is, unloading due to distraction and<br>positioning. | Indications for use<br>The Triton/ Tru-Trac/TX/Triton DTS Traction devices provide<br>traction and mobilization of skeletal structures and skeletal<br>muscles.<br>The Triton/ Tru-Trac/TX/Triton DTS Traction devices provide<br>a treatment in static, intermittent, progressive, regressive and<br>cycling distraction forces to relieve pressures on structures that<br>may be causing pain of skeletal or muscular origin (cervical,<br>thoracic,<br>lumbar, hip, wrist, shoulder). Therapeutic distraction can be<br>applied in a variety of programmable patterns., cycles and<br>functions.<br>The Triton/ Tru-Trac/ TX/ Triton DTS "Traction devices with<br>the optional EMG (a.k.a. sEMG) biofeedback feature may be<br>used to relieve peripheral radiation/sciatica<br>and pain associated with:<br>• Protruding discs<br>• Bulging discs<br>• Herniated discs<br>• Degenerative disc disease<br>• Posterior facet syndrome<br>• Acute facet problems<br>• Radicular pain<br>• Prolapsed discs<br>• Spinal root impingement<br>• Hypomobility<br>• Degenerative joint disease<br>• Facet syndrome<br>• Compressions fractures<br>• Joint pain<br>• Discogenic pain<br>EMG (a.k.a. sEMG)<br>Determination of the activation magnitude and timing of<br>muscles for:<br>a) retraining of muscle activation<br>b)coordination of muscle activation<br>- Determination of the force produced by muscle for control<br>and maintenance of muscle contractions. |

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| | | | - Relaxation muscle training. |
|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | -Muscle re-education |
| Intended Use | Decompression of intervertebral discs of the cervical spine. | Decompression of intervertebral discs of the cervical spine.<br>Alternative uses for decompression of intervertebral discs of<br>the thoracic or lumbar. | Decompression of intervertebral discs of the cervical spine.<br>Alternative uses for decompression of intervertebral discs of<br>the thoracic or lumbar. |
| Target Population | The intended patient population is adults of all ages. | The intended patient population is adults of all ages. | The intended patient population is adults of all ages. |
| Anatomical Site | Cervical spine | Cervical spine. Alternative uses for other anatomical sites. | Cervical spine. Alternative uses for other anatomical sites. |
| Maximum cervical traction<br>tension force i.e., energy<br>delivered | 40 pounds | 40 pounds | 40 pounds |
| Human Factors | Rotating display screen for clinician ease for viewing | Rotating display screen for clinician ease for viewing | Rotating display screen for clinician ease for viewing |
| Design | Painted sheet metal and ABS plastic encasement housing<br>electronic circuitry; software and electronics engage a gear<br>driven motor with load sensors; slide mechanism, and patient<br>head harness to apply cervical traction. | ABS plastic encasement housing electronic circuitry; software<br>and electronics engage a gear driven motor with load sensors;<br>rope mechanism, and patient head mechanism to apply cervical<br>traction. | ABS plastic encasement housing electronic circuitry; software<br>and electronics engage a gear driven motor with load sensors;<br>rope mechanism, and patient head mechanism to apply cervical<br>traction. |
| Electrical medical standards | AAMI/ANSI/ES 60601-1: 2005 Ed. 3/ IEC60601-1:2005 Ed.3 | IEC60601-1:1988 Ed. 2 | IEC60601-1:1988 Ed. 2 |
| meet | (FDA, Standard Recognition #19-5) | (FDA, Standard Recognition #5-4) | (FDA, Standard Recognition #5-4) |
| Electromagnetic compatibility<br>i.e., compatibility with the<br>environment and other devices | AAMI/ANSI/IEC 60601-1-2 :2007 Ed. 3 (FDA, Standard<br>Recognition #19-2) | IEC 60601-1-2:2001 Ed.2<br>(FDA Standard Recognition #5-28) | IEC 60601-1-2:2001 Ed.2<br>(FDA Standard Recognition #5-28) |
| Preset protocols - | Yes | Yes | Yes |
| Protocol name: | Cervical TX | Disc Involvement with muscle guarding | Disc Involvement with muscle guarding |
| Protocol Speed (%): | 30 | 30 | 30 |
| Protocol total time (Min): | 17 | 17 | 17 |
| Progressive Stage - Traction | Static | Static | Static |
| type: | 6 | 6 | 6 |
| Steps: | 10 | 10 | 10 |
| Hold (Sec):<br>Rest (Sec): | 0 | 0 | 0 |
| Traction Stage - Traction type: | Intermittent | Intermittent | Intermittent |
| Steps: | 0 | 0 | 0 |
| Hold (Sec): | 60 | 60 | 60 |
| Rest (Sec): | 20 | 20 | 20 |
| Time (Min): | 15 | 15 | 15 |
| Regressive Stage - Traction | Static | Static | Static |
| type: | 6 | 6 | 6 |
| Steps: | 10 | 10 | 10 |
| Hold (Sec):<br>Rest (Sec): | 0 | 0 | 0 |
| Power source | Automatic switchable power supply 100-240VAC, 50/60Hz<br>+/- 10% tolerance - charging a Lithium Ion Battery, 3.2V-<br>3200mAh | Automatic switchable power supply 100-240VAC, 50/60Hz<br>+/- 10% tolerance | Automatic switchable power supply 100-240VAC, 50/60Hz<br>+/- 10% tolerance |
| Mechanical Safety - Traction<br>force can be halted and traction<br>tension released by a patient | Yes | Yes | Yes |
| held stop switch if the patient<br>feels discomfort during traction<br>therapy | | | |
| Steps down mains power to<br>operate internal electronics and<br>components at low voltage | Yes | Yes | |
| Operates from battery source | Yes | No | |
| Battery type | Rechargeable lithium ion 3200mAh | N/A | |
| Software | Yes | Yes | |
| Accessories | Patient head halter without ridged | Patient head halter with ridged bolsters | |
| Weight (lbs., oz.) | 23.8lbs (10.8kg)…