(112 days)
Not Found
No
The device description and intended use focus on mechanical compression and cold therapy with a pre-programmed air pump. There is no mention of AI or ML in the provided text, and the "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device's stated indications for use, such as "temporary relief of minor muscle aches and pains" and "temporary increase in circulation," align with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The provided text explicitly states the device's indications for use are for temporary relief of muscle aches, increased circulation, and localized cold therapy. It performs physical functions (compression, cold) for therapeutic purposes, rather than diagnosing conditions.
No
The device description explicitly lists hardware components such as a pump-controller unit, a wrap with an air bladder, and a reusable thermogel cold pack.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the device is for the temporary relief of minor muscle aches and pains, temporary increase in circulation, and localized cold therapy. These are all physical therapies applied externally to the body.
- Device Description: The description details a physical device that applies compression and cold therapy. It involves a pump, inflatable garments, and cold packs. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
- Measuring biomarkers.
The device falls under the category of a physical therapy or rehabilitation device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IRP; IME
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:
-
- 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.
-
- 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.
-
- Reusable thermogel cold pack
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg, foot, feet, arm, shoulders, lower back, and hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No performance standards have been promulgated for this device. Bench and EMC testing has been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K030437 Relaxor Perfect Touch Air Massaging System, Salton, Inc., product code IRP, K112479 DSJ Massager, Mego Afek, product code IRP
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
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.(b)
Classification. Class II (performance standards).
0
Portable Therapeutix Squid Active Cold Compression device and Cold Pack Traditional 510(k) Premarket-Notification Submission
K123829
| Traditional 510(k) Summary | |
|---|---|
| A) | |
| Submitted by: | Portable Therapeutix |
| 6446 Auden Street | |
| Houston, TX 77005 | |
| 1-617-331-7524 | |
| Contact: | Sharyn Orton, Ph.D. |
| MEDIcept, Inc. | |
| 200 Homer Ave | |
| Ashland, MA 01721 | |
| 401-330-8264 | |
| B) Classification Name: | Massager, Powered Inflatable Tube - Product code IRP |
| Pack, Cold, Reusable - Product code IME | |
| Common Name: | Powered inflatable tube massager |
| Cold Pack | |
| Proprietary Name: | Portable Therapeutix Squid Active Cold Compression device and |
| Cold Pack | |
| Device Regulations: | |
| and Class | 21 CFR 890.5650, Class II |
| 21 CFR 890.5700, Class I 510(k) exempt | |
| Product Codes: | IRP; IME |
| C) Predicates: | K030437 Relaxor Perfect Touch Air Massaging System, Salton, Inc., |
| product code IRP | |
| 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:
-
- 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.
l - l
- 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.
1
Portable Therapeutix Squid Active Cold Compression device and Cold Pack Traditional 510(k) Premarket-Notification Submission
-
- 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.
-
- 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.
2
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.
Relaxor Perfect Touch Air Massaging System | Mego Afek
DJS Massager |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indication for
Use | IRP; IME
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. | K030437
IRP
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
IRP
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 |
l -3
3
Portable Therapeutix
tional 510(k) Premarket-Notification Sub
o be used over cotton clothing
Not specified Extraust vent
115V ~60 Hz; consumpti
2W K112479_______________________________________________________________________________________________________________________________________________________________________ nt - 20-30 mm Hg
dium – 40-60 mm
nse – 70 – 80 mm Mego Afek
JS Massag -- 45 minute – 80 mm 1 xhaust ven No batter Pump No Salton, Inc.
Ixor Perfect Touch
Massaging System Nylon with TPU backin
wrap- yes 0V 60 Hz, consump
W; AC adapter: 120
, consumption 36W K030437
ermittent compressi
ntensity settings essurization pun icroprocess aust valve 5 minutes No batter No 0V 60 Hz, consumption 26
C adapter: 120V 60 Hz,
Isumption 36W on with TPU backing wr table Therapeutix St
etive Cold Compress
device and Cold Pack roprocessor and press mittent compression
ensity settings (mod ssurization pum
haust valve – 30 mm Hg
– 50 mm Hg
– 70 mm Hgg
– 85 mm Hgg ithium batte 85 mm H minute ensor Yes otal treatment tim ressure contro essure range iocompatibl Principle of
Operation/
Mechamical
Techanical
Tharacteristi ower sourc nflation by Cold Pack
『「
4
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.
5
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.
6
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 (800) 638-2041 or (301) 796-7100 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
7
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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