(140 days)
Not Found
No
The description details a mechanical compression device with sequential inflation/deflation controlled by the main body, with no mention of AI or ML capabilities.
Yes
The device is intended for the temporary relief of minor muscle aches and pains and temporary increase in blood circulation, which are therapeutic uses.
No
The device is described as providing temporary relief of muscle aches and pains and increasing blood circulation, which are therapeutic functions, not diagnostic ones. Its operation involves sequential inflation and deflation of cuffs to apply pressure, without any mention of analyzing physiological data for diagnostic purposes.
No
The device description explicitly lists hardware components such as a main body, power cord, cuffs, and hoses, indicating it is a physical device with software control, not a software-only device.
Based on the provided information, the POWER-Q2300 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the temporary relief of muscle aches and pains and temporary increase in blood circulation. This is a physical therapy/rehabilitation type of use, not a diagnostic one.
- Device Description: The device applies pressure to the body using inflatable cuffs. This is a mechanical action, not a test performed on biological samples.
- Lack of Biological Sample Testing: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The POWER-Q2300 does not interact with or analyze biological samples.
Therefore, the POWER-Q2300 falls under the category of a physical medicine or rehabilitation device, not an IVD.
N/A
Intended Use / Indications for Use
POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading of tissues by using an inflatable garment (cuff).
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
POWER-Q2300 is comprised of a main body, a power cord, cuffs, and hoses for connecting the device to the cuffs. The device is AC-powered. There are four cuffs to apply to different body areas, such as leg, arm, hip, and half-leg. The cuffs have 4-chambers. The cuff inflates and deflates sequentially to apply the pressure on the target body areas which are controlled by the main body.
Double hose is to connect main body and leg cuff. Single hose is to connect main body and arm cuff (or hip cuff or half-leg cuff). Extension zipper is for bigger leg. Blocked jack is to block an air outlet that will not be used. The colors of the cuffs and extension zipper are available in pink or gray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Leg (including of foot, calf, knee, upper leg)
Hip (including of upper leg, glutes, hips, lower lack)
Arm (including of entire arm, shoulder)
Half-Leg (including of foot, calf, knee)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinics, hospital, athlete training, and home environments
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 Testing:
The device has been tested and met the requirements of the following standards:
IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ANSVAAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for safety and essential performance - Collateral Standard: Usability
IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 62366-1 Edition 1.0 2015-02 Medical device – Part 1: Application of usability engineering to medical devices
IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle process
Performance testing for pressure accuracy, seam strength, and fail mode testing has been performed.
Clinical Testing:
No clinical testing was performed.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
September 14, 2021
Wonjin Mulsan Co., Ltd. HaYong Jung QMR 89. Geomdan-ro. Seo-gu Incheon, 22653 Republic of Korea
Re: K211283
Trade/Device Name: Compressible Limb and Circulation Therapy System, Model POWER-02300 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: August 24, 2021 Received: August 31, 2021
Dear HaYong Jung:
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. 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 located 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211283
Device Name
Compressible Limb and Circulation Therapy System, Model POWER-Q2300
Indications for Use (Describe)
POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading of tissues by using an inflatable garment (cuff).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
[as required by 21 CFR 807.02]
| Date Prepared: | Sep. 8, 2021 |
|---|---|
| Submitter: | Wonjin Mulsan Co., Ltd. |
| 89, Geomdan-ro, Seo-gu, Incheon, 22653, Republic of Korea | |
| Tel: 82-32-816-0552, Fax: 82-32-816-0557 | |
| Establishment Registration Number: 3006797972 | |
| Contact Person: HaYong Jung | |
| Email: wonjin@wonjininc.com | |
| Trade Name: | Compressible Limb and Circulation Therapy System |
| Model POWER-Q2300 | |
| Common Name: | Powered Inflatable Tube Massager |
| Classification Name: | Massager, Powered Inflatable Tube |
| Regulation Number: | 890.5650 |
| Product Code: | IRP |
| Classification: | Class II |
| Predicate Device: | Rapid Reboot Compression Therapy System which was cleared for |
| marketing under K182668 |
Device Description
POWER-Q2300 is comprised of a main body, a power cord, cuffs, and hoses for connecting the device to the cuffs. The device is AC-powered. There are four cuffs to apply to different body areas, such as leg, arm, hip, and half-leg. The cuffs have 4-chambers. The cuff inflates and deflates sequentially to apply the pressure on the target body areas which are controlled by the main body.
Double hose is to connect main body and leg cuff. Single hose is to connect main body and arm cuff (or hip cuff or half-leg cuff). Extension zipper is for bigger leg. Blocked jack is to block an air outlet that will not be used. The colors of the cuffs and extension zipper are available in pink or gray.
Indications for Use
POWER-Q2300 is intended for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading and stroking of tissues by using an inflatable garment (cuff).
| Item | Description |
|---|---|
| Operation Mode | 4 modes such as Mode A, Mode B, Mode C, and Mode D |
| Pressure Range | 20 mmHg to 200 mmHg |
| Operation Time | 15 and 30 minutes |
| Rest Time | Adjustable at interval of 0/5/10/30 sec at modes A and B |
| Fixed at 30 sec at modes C and D |
Technologic Characteristics
4
Non-Clinical Testing
The device has been tested and met the requirements of the following standards:
IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ANSVAAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for safety and essential performance - Collateral Standard: Usability
IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 62366-1 Edition 1.0 2015-02 Medical device – Part 1: Application of usability engineering to medical devices
IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle process
Performance testing for pressure accuracy, seam strength, and fail mode testing has been performed.
The biocompatibility of the materials has not been verified by the FDA and contact of the cuffs/ accessories to direct skin may lead to skin irritation, skin sensitization and/or cytotoxicity. The device is intended to be used only over clothing.
Clinical Testing
No clinical testing was performed.
Conclusions
Wonjin Mulsan Co., Ltd. believes that all applicable items of information specified in this submission have been supplied in full. The enclosed non-clinical data demonstrate that the subject device described herein raises no new questions concerning safety or effectiveness and may therefore be properly considered by the Agency as substantially equivalent to the predicate device that has previously been legally distributed in interstate commerce in the United States.
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Comparison with Predicate Devices
| Item | Subject Device | Predicate Device | Differences Discussion |
|---|---|---|---|
| Model | POWER-Q2300 | Rapid Reboot Compression Therapy System | NA |
| Manufacturer | Wonjin Mulsan Co., Ltd. | Rapid Reboot Recovery Products, LLC | NA |
| Classification | Class II Device, IRP (21 CFR 890.5650) | Class II Device, IRP (21 CFR 890.5650) | NA |
| 510(k) number | K182668 | NA | |
| Indications for use | POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading and stroking of tissues by using an inflatable garment (cuff). | The Rapid Reboot Compression Therapy 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 Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment. | Identical |
| Prescriptive or OTC | OTC | OTC | Identical |
| Environment of Use | Clinics, hospital, athlete training, and home environments | Clinics, hospital, athlete training, and home environments | Identical |
| Power Source(s) | 110-120VAC, 50/60Hz | 110VAC, 60Hz | Minor difference |
| Weight | 3.1 kg | 2.63 kg (5.8 pounds) | Minor difference |
| Dimensions (W x H x D) | 290 x 260 x 172 mm | 25.4 x 16.51 x 12.7 cm (10" x 6.5" x 5") | Minor difference |
| Device pressure range | 20-200 mmHg | 0-200 mmHg | Pressure range of subject device is smaller than that of predicate device. |
| Treatment Time | User can select operation time from 15 and 30 minutes. | User determines therapy time. Choose from 10, 20, or 30 minute session time, with option | Minor difference |
| to add additional 10 minutes to | |||
| any therapy time. | |||
| Number of | |||
| inflatable | |||
| appliance | |||
| segments | 4 | 4 | Identical |
| Anatomical | |||
| site | Leg (including of foot, calf, | ||
| knee, upper leg) | |||
| Hip (including of upper leg, | |||
| glutes, hips, lower lack) | |||
| Arm (including of entire arm, | |||
| shoulder) | |||
| Half-Leg (including of foot, | |||
| calf, knee) | Leg (including of foot, calf, | ||
| knee, upper leg) | |||
| Hip (including of upper leg, | |||
| glutes, hips, lower lack) | |||
| Arm (including of entire arm, | |||
| shoulder, upper chest and back) | Identical except | ||
| half-leg | |||
| Mode of | |||
| compression | 4 modes (Mode A, Mode B, | ||
| Mode C and Mode D) | 2 modes (Sequential and | ||
| Peristaltic) | Refer to the | ||
| visual | |||
| description | |||
| below. | |||
| Mode of | |||
| compression | |||
| (visual | |||
| description) | Image: Mode A | Image: Mode A | Mode A of |
| POWER-Q2300 | |||
| is similar to | |||
| Mode A of the | |||
| predicate. | |||
| Image: Mode B | Image: Mode A | Mode B of | |
| POWER-Q2300 | |||
| is identical to | |||
| Mode A of the | |||
| predicate. | |||
| Image: Mode C | Image: Mode B | Mode C of | |
| POWER-Q2300 | |||
| is identical to | |||
| Mode B of the | |||
| predicate. | |||
| Image: Mode D | Image: Mode A | ||
| Image: Mode B | Mode D of | ||
| POWER-Q2300 | |||
| is a combination | |||
| of Mode B and | |||
| Mode C, and is | |||
| identical to a | |||
| combination of | |||
| Mode A and | |||
| Mode B of the | |||
| predicate. | |||
| Appearance | |||
| and size of | |||
| Cuffs | Leg | Leg | Minor |
| difference | |||
| Image: Leg cuffs | Image: Leg cuffs | ||
| X-Short: 14" x 41" | |||
| Short: 14" x 43" | |||
| Medium: 14" x 45" | |||
| Long: 14" x 48" | |||
| X-Long: 14" x 52" | |||
| Image: Leg cuff | Minor difference | ||
| Image: Leg cuff with dimensions | |||
| 310 | |||
| 940 | |||
| Medium: 310x940mm | |||
| Large: 390x990 | |||
| Hip | |||
| Image: Hip cuff | Hip | ||
| Image: Hip cuff | |||
| Regular: | |||
| 26" x 32" | |||
| Large: 26" | |||
| 35" | |||
| Image: Hip cuff | Minor | ||
| difference | |||
| Image: Hip cuff with dimensions | |||
| 530 | |||
| 720 | |||
| 530x720mm | |||
| Arm | |||
| Image: Arm cuff | Arm | ||
| Image: Arm cuffs | |||
| Regular: 18" x 38" | |||
| Long: 18" x 44" | |||
| Image: Arm cuff | Minor | ||
| difference | |||
| Image: Arm cuff with dimensions | |||
| 255 | |||
| 870 | |||
| Medium: 255x870mm | |||
| Large: 330x895mm | |||
| Half-Leg | None | Minor | |
| difference | |||
| Other | |||
| accessories | Image: Half-Leg | ||
| Image: Half-Leg with dimensions 300, 700 | |||
| 300x700mm | |||
| Extension zipper | |||
| Image: Extension zipper with dimensions 120, 900 | |||
| Medium: 120x900mm | |||
| Large: 150x950mm | |||
| Double hose | |||
| Image: Double hose | |||
| Length: 1,430mm | |||
| Single hose | |||
| Image: Single hose | |||
| Length: 1,320mm | |||
| Blocked jack | |||
| Image: Blocked jack with dimensions 47.1, 13.9, 53.8 | |||
| 53.8x47.1x13.9mm | "Not publicly available in the | ||
| official 510K Summary" | Minor | ||
| difference |
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