(361 days)
Not Found
No
The description focuses on mechanical inflation/deflation cycles and does not mention any AI/ML components or algorithms for controlling the device's operation.
Yes.
The device is intended for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation, which are therapeutic claims.
No
The device is intended for temporary relief of minor muscle aches and pains and increasing blood circulation, which are therapeutic functions, not diagnostic ones. It does not identify or characterize diseases or conditions.
No
The device description explicitly lists hardware components such as a main body, AC-DC adapter, cuffs with hoses, and a hose adapter. It is a physical system that uses inflation and deflation of cuffs to provide therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The POWER RECOVERY device is a physical therapy device that uses inflatable cuffs to apply pressure and simulate massage. It works externally on the body to provide temporary relief of muscle aches and improve circulation.
- Intended Use: The intended use clearly states it's for "temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas." This is a physical therapy application, not a diagnostic test performed on samples.
- Device Description: The description details the mechanical components and how it applies pressure to the body. There is no mention of analyzing biological samples.
Therefore, the POWER RECOVERY device falls under the category of a physical therapy or massage device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
POWER RECOVERY 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 RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
Compressible Limb and Circulation Therapy System Model POWER RECOVERY is a powered inflatable tube massager, and comprised of a main body, an AC-DC adapter, cuffs with hose, and a hose adapter and a main hose for connecting the device to the cuffs. The device is powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. There are three cuffs to apply to different body areas, such as leg, arm, and hip. Leg cuff and arm cuff have 6-chambers and hip cuff has 5-chambers. The cuffs can be inflating and deflating sequentially to apply the pressure on the target body areas which are controlled by the main body. The device simulates kneading and stroking of tissues by using an inflatable garment (cuff) to temporarily relieve minor muscle aches and pains and to temporarily increase blood circulation to the tested areas in people who are in good health.
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)
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)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2021
Wonjin Mulsan Co., Ltd Ha Yong Jung 89, Geomdan-ro, Seo-gu, Incheon, 22653 Republic of Korea
Re: K200660
Trade/Device Name: Compressible Limb and Circulation Therapy System, Model POWER RECOVERY Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: December 8, 2020 Received: December 15, 2020
Dear Ha 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.
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
1
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 mediation-emitting products, including information about labeling regulations, please see Device (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,
Heather Dean, PhD Assistant Director. Acute Injury Devices 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K200660
Device Name
Compressible Limb and Circulation Therapy System, Model POWER RECOVERY
Indications for Use (Describe)
POWER RECOVERY 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 RECOVERY simulates kneading and stroking 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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3
510(K) Summary
[as required by 21 CFR 807.02]
| Date Prepared: | Feb. 17, 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 RECOVERY | |
| 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
Compressible Limb and Circulation Therapy System Model POWER RECOVERY is a powered inflatable tube massager, and comprised of a main body, an AC-DC adapter, cuffs with hose, and a hose adapter and a main hose for connecting the device to the cuffs. The device is powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. There are three cuffs to apply to different body areas, such as leg, arm, and hip. Leg cuff and arm cuff have 6-chambers and hip cuff has 5-chambers. The cuffs can be inflating and deflating sequentially to apply the pressure on the target body areas which are controlled by the main body. The device simulates kneading and stroking of tissues by using an inflatable garment (cuff) to temporarily relieve minor muscle aches and pains and to temporarily increase blood circulation to the tested areas in people who are in good health.
Indications for Use
POWER RECOVERY 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 RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).
| Item | Description |
|---|---|
| Operation Mode | 5 modes such as SEQUENTIAL, ADDITION and MASSAGE |
| Pressure Range | Level 1 (60 mmHg) to Level 10 (150 mmHg) |
| Operation Time | 10, 20, and 30 minutes |
| Rest Time | Adjustable at interval of 0/5/10/30 sec at SEQUENTIAL mode |
| Fixed at 30 sec at ADDITION and MASSAGE modes |
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 ANSI/AAMI HA60601-1-11:2015
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
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.
5
Comparison with Predicate Devices
| Item | Subject Device | Predicate Device | Differences |
|---|---|---|---|
| Discussion | |||
| Model | POWER RECOVERY | 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 | K200660 | K182668 | NA |
| Indications for | |||
| use | POWER RECOVERY 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 RECOVERY | |||
| 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) | 15 VDC via in IEC 60601-1 | ||
| compliant power supply | |||
| (100-240 VAC input), | |||
| Optional integrated | |||
| rechargeable battery | 110VAC, 60Hz | Minor | |
| difference | |||
| Weight | 2 kg including battery | 2.63 kg (5.8 pounds) | Minor |
| difference | |||
| Dimensions | |||
| (W x H x D) | 114 x 141 x 245 mm | 25.4 x 16.51 x 12.7 cm | |
| (10" x 6.5" x 5") | Minor | ||
| difference | |||
| Device | |||
| pressure range | 60-150 mmHg | 0-200 mmHg | Pressure range |
| of subject | |||
| device is smaller | |||
| than that of | |||
| predicate | |||
| device. | |||
| Treatment | |||
| Time | User can select operation | ||
| time among 10, 20, and 30 | |||
| minutes. | User determines therapy time. | ||
| Choose from 10, 20, or 30 | |||
| minute session time, with option | |||
| to add additional 10 minutes to | |||
| any therapy time. | Identical | ||
| Number of | |||
| inflatable | |||
| appliance | |||
| segments | 6 or less for leg and arm | ||
| cuffs | |||
| 5 or less for hip cuff | 4 | Minor | |
| difference | |||
| Sleeve and | |||
| chamber | Leg: 6-chambers | ||
| Arm: 6-chambers | |||
| Hip: 5-chambers | Leg: 4-chambers | ||
| Arm: 4-chambers | |||
| Hip: 4-chambers | Minor | ||
| difference | |||
| 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) | 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 | ||
| Mode of | |||
| compression | Sequential, Addition, and | ||
| Massage | Sequential and Peristaltic | Refer to the | |
| visual | |||
| description | |||
| below. | |||
| Mode of | |||
| compression | |||
| (visual | |||
| description) | Sequential | ||
| Image: Sequential compression | Mode A | ||
| Image: Mode A compression | Sequential mode | ||
| of POWER | |||
| RECOVERY is | |||
| similar to Mode | |||
| A of the | |||
| predicate. | |||
| Addition | |||
| Image: Addition compression | Mode B | ||
| Image: Mode B compression | Addition mode | ||
| of POWER | |||
| RECOVERY is | |||
| similar to Mode | |||
| B of the | |||
| predicate. | |||
| Massage: | |||
| Combination of | |||
| SEQUENTIAL and Addition | |||
| modes | None | Massage mode | |
| of POWER | |||
| RECOVERY is | |||
| a combination | |||
| of | |||
| SEQUENTIAL | |||
| and Addition | |||
| modes. |
6
7
Image /page/7/Picture/0 description: The image shows the appearance and size of cuffs for legs and hips. The leg cuffs are shown in two different styles, one with the word "RECOVERY" and the other with "RAPID REBOOT". The dimensions of the leg cuffs are 355x97mm (14" x 38.4") and X-Short: 14" x 41", Short: 14" x 43", Medium: 14" x 45", Long: 14" x 48", X-Long: 14" x 52". The hip cuffs are also shown in two different styles, with dimensions of 780x775mm (30.7" x 30.5") and Regular: 26" x 32", Large: 26" x 35".
8
| | Arm
Image: Arm sleeves
Image: Arm sleeve dimension
300x945mm
(11.8" x 37.2") | Arm
Image: Arm wraps
Regular: 18" x 38"
Long: 18" x 44" | Minor
difference |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------|
| Other
accessories | Image: AC-DC Adapter
AC-DC Adapter
Image: Main Hose and Hose Adapter
Main Hose Hose Adapter
Image: Carrier
Carrier | "Not publicly available in the
official 510K Summary" | Minor
difference |