PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK

K123829 · Portable Therapeutix, LLC · IRP · Apr 3, 2013 · Physical Medicine

Device Facts

• Record ID: K123829
• Device Name: PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
• Applicant: Portable Therapeutix, LLC
• Product Code: IRP · Physical Medicine
• Decision Date: Apr 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains. The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment. The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.

Device Story

Device combines intermittent pneumatic compression with cold therapy; consists of portable pump-controller, inflatable garment (wrap), and reusable thermogel cold pack. Pump-controller uses microprocessor to manage sequential compression cycles; provides four intensity settings (30, 50, 70, 85 mm Hg). User applies wrap to leg, foot, arm, shoulder, lower back, or hand; connects to pump via flexible tube. Powered by AC-DC supply or internal lithium battery. Simulates kneading/stroking of tissues to increase circulation; cold pack provides localized cooling. Used by patients for temporary relief of minor muscle aches/pains. Healthcare provider determines necessity of cold therapy. Benefits include combined compression and cooling for musculoskeletal comfort.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through bench and EMC testing; complies with IEC 60601-1 safety standards.

Technological Characteristics

Portable pneumatic pump-controller with microprocessor; inflatable wrap with sequential compression; reusable thermogel cold pack. Power: AC-DC or internal lithium battery. Pressure range: 30-85 mm Hg. Biocompatible materials. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for temporary relief of minor muscle aches and pains, and temporary increase in circulation in healthy individuals. Cold pack indicated for localized cold therapy as determined by a physician. Applicable to leg, foot, arm, shoulders, lower back, and hands.

Regulatory Classification

Identification

A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.

Predicate Devices

• Relaxor Perfect Touch Air Massaging System (K030437)
• DSJ Massager (K112479)

Submission Summary (Full Text)

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## Portable Therapeutix Squid Active Cold Compression device and Cold Pack Traditional 510(k) Premarket-Notification Submission

#### K123829

| | Traditional 510(k) Summary |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| A)<br>Submitted by: | Portable Therapeutix<br>6446 Auden Street<br>Houston, TX 77005<br>1-617-331-7524 |
| Contact: | Sharyn Orton, Ph.D.<br>MEDIcept, Inc.<br>200 Homer Ave<br>Ashland, MA 01721<br>401-330-8264 |
| B) Classification Name: | Massager, Powered Inflatable Tube - Product code IRP<br>Pack, Cold, Reusable - Product code IME |
| Common Name: | Powered inflatable tube massager<br>Cold Pack |
| Proprietary Name: | Portable Therapeutix Squid Active Cold Compression device and<br>Cold Pack |
| Device Regulations:<br>and Class | 21 CFR 890.5650, Class II<br>21 CFR 890.5700, Class I 510(k) exempt |
| Product Codes: | IRP; IME |
| C) Predicates: | K030437 Relaxor Perfect Touch Air Massaging System, Salton, Inc.,<br>product code IRP<br>K112479 DSJ Massager, Mego Afek, product code IRP |

#### D) Device Description:

The Squid Active Cold Compression device and Cold Pack combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a pre-programmed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.

The device is manufactured with the following components:

- 1. A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
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## Portable Therapeutix Squid Active Cold Compression device and Cold Pack Traditional 510(k) Premarket-Notification Submission

- 2. A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
- 3. Reusable thermogel cold pack

E) Intended Use/Indication for Use:

The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains.

The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.

The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.

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quid Active Cold Compression device and Cold Pack
raditional 510(k) Premarket-Notification Submission

Comparison to Predicate Device(s) (ਮ

.

| Product code | Portable Therapeutix Squid Active Cold Compression device and Cold Pack | Salton, Inc.<br>Relaxor Perfect Touch Air Massaging System | Mego Afek<br>DJS Massager |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indication for<br>Use | IRP; IME<br><br>The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains.<br><br>The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment. The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable. | K030437<br>IRP<br><br>The Perfect Touch Air Massaging System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Perfect Touch simulates kneading and stroking of tissues by using an inflatable garment. | K112479<br>IRP<br><br>The DJS Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The DJS Massager simulates kneading and stroking of tissues by using an inflatable garment. |
| Target | Leg, foot, arm, shoulders, lower back, hands | Leg & foot, feet, arm, neck and shoulders, lower back, hands | Boot, leg, arm/shoulder |

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## Portable Therapeutix Squid Active Cold Compression device and Cold Pack Traditional 510(k) Premarket-Notification Submission

## Substantial Equivalence Discussion

The Portable Therapeutic Active Cold Compression device and Cold Pack has the same intended use, similar target treatment areas, and similar mechanical intermittent compression as the predicate devices. Pressure intensities are for patient comfort only, and differences do not raise new issues of safety or effectiveness. The addition of a cold pack also does not raise new issues of safety or effectiveness.

#### Performance

No performance standards have been promulgated for this device. Bench and EMC testing has been conducted.

#### Conformity to Standards

There are no FDA recognized consensus standards for this device.

This device complies with IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995

### Conclusion

The Portable Therapeutix Squid Active Cold Compression device and Cold Pack is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.

#### April 3,2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609

Silver Spring, MD 20993-0002

Public Health Service

Portable Therapeutix LLC % Sharyn Orton, Ph.D. MEDIcept, Inc. 200 Homer Ave. Ashland, MA 01721

Re: K123829

Trade/Device Name: Squid Active Cold Compression Device and Cold Pack Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IME Dated: February 27, 2013 Received: February 28, 2013

Dear Dr. Orton:

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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Sharyn Orton, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Sincerely yours,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting 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): K123829

### Device Name: Portable Therapeutix Squid Active Cold Compression device and Cold Pack

Indications for Use:

The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains.

The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.

The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.

Prescription Use X X Over-the-Counter Use AND/OR (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) . .

Concurrence of CDRH, Office of Device Evaluation and Safety (ODE)

Victor Krauthamer -S 2013.04.03 17:37:46 -04'00'

Division of Neurological and Physical Medicine Devices 510(k) Number: K123829

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