(361 days)
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).
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.
The provided text describes a 510(k) premarket notification for the "Compressible Limb and Circulation Therapy System, Model POWER RECOVERY" and its comparison to a predicate device, the "Rapid Reboot Compression Therapy System."
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics. It does not present a table of specific acceptance criteria (e.g., minimum sensitivity/specificity thresholds) or quantitative performance metrics typically seen in studies evaluating the diagnostic or predictive accuracy of a device.
Instead, the "acceptance criteria" here are implicitly related to meeting safety and performance standards for a powered inflatable tube massager and having indications for use and technological features that are substantially equivalent to a legally marketed predicate device.
| Category | Acceptance Criteria (Implicit from 510(k) process and comparison) | Reported Device Performance (as presented) |
|---|---|---|
| Safety & Essential Performance Standards | Compliance with relevant medical electrical equipment and usability standards for safety and essential performance. | 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)2012IEC 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 HA60601-1-11:2015IEC 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)The device has been tested and met the requirements of these standards. |
| Indications for Use | Indications for use must be substantially equivalent to the predicate device. | POWER RECOVERY: "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).Predicate Device: "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."Reported as "Identical." |
| Technological Characteristics | Key technological characteristics (operation mode, pressure range, cuffs, etc.) should not raise new questions of safety or effectiveness compared to the predicate. | Operation Mode: 5 modes (SEQUENTIAL, ADDITION, MASSAGE) vs. 2 (Sequential, Peristaltic). Massage mode of subject device is a combination of SEQUENTIAL and Addition modes, which are similar to predicate modes.Pressure Range: 60-150 mmHg vs. 0-200 mmHg. Subject device has a smaller pressure range.Number of Inflatable Appliance Segments: 6 or less for leg/arm, 5 or less for hip vs. 4. Subject device has more segments.Sleeve and Chamber: Leg: 6-chambers, Arm: 6-chambers, Hip: 5-chambers vs. Leg: 4-chambers, Arm: 4-chambers, Hip: 4-chambers. Subject device has more chambers.Power Source(s): 15 VDC via IEC 60601-1 compliant power supply (100-240 VAC input), Optional integrated rechargeable battery vs. 110VAC, 60Hz. Minor difference.Weight: 2 kg including battery vs. 2.63 kg (5.8 pounds). Minor difference.Dimensions: 114 x 141 x 245 mm vs. 25.4 x 16.51 x 12.7 cm (10" x 6.5" x 5"). Minor difference.Treatment Time: User can select 10, 20, and 30 minutes vs. User determines therapy time, choose from 10, 20, or 30 minute session time, with option to add additional 10 minutes. Reported as "Identical."Anatomical site: Identical.Prescriptive or OTC: Identical (OTC).Environment of Use: Identical. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical testing was performed." Therefore, there is no test set in the sense of a clinical trial or a dataset of patient cases. The evaluation relies entirely on non-clinical testing for standards compliance and a comparison of technical specifications to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as no clinical testing or test set involving expert ground truth existed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical testing or test set involving expert ground truth existed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical therapeutic device (powered inflatable tube massager), not an AI-based diagnostic or imaging interpretation system. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical therapeutic device, not an algorithm, and does not operate in a standalone algorithmic capacity as would be understood in the context of AI or diagnostic software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device (a massager), ground truth related to diagnostic accuracy is irrelevant. The "ground truth" for its safety and claimed physiological effects (e.g., temporary increase in blood circulation) would typically come from well-controlled clinical studies demonstrating these effects, but the document states "No clinical testing was performed." Instead, compliance with safety and performance standards and substantial equivalence to a predicate device with established safety and efficacy (for its limited indications) forms the basis of its clearance.
8. The sample size for the training set
Not applicable. The device is a physical therapeutic device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable for the reason stated above.
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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
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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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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 KoreaTel: 82-32-816-0552, Fax: 82-32-816-0557Establishment Registration Number: 3006797972Contact Person: HaYong JungEmail: wonjin@wonjininc.com |
| Trade Name: | Compressible Limb and Circulation Therapy SystemModel 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 formarketing 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 modeFixed at 30 sec at ADDITION and MASSAGE modes |
Technologic Characteristics
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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.
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Comparison with Predicate Devices
| Item | Subject Device | Predicate Device | Differences |
|---|---|---|---|
| Discussion | |||
| Model | POWER RECOVERY | Rapid Reboot CompressionTherapy System | NA |
| Manufacturer | Wonjin Mulsan Co., Ltd. | Rapid Reboot RecoveryProducts, LLC | NA |
| Classification | Class II Device, IRP (21CFR 890.5650) | Class II Device, IRP (21 CFR890.5650) | NA |
| 510(k) number | K200660 | K182668 | NA |
| Indications foruse | POWER RECOVERY isintended for the temporaryrelief of minor muscle achesand pains, and for temporaryincrease in blood circulationto the treated areas in peoplewho are in good health.POWER RECOVERYsimulates kneading andstroking of tissues by usingan inflatable garment (cuff). | The Rapid Reboot CompressionTherapy System is indicated forthe temporary relief of minormuscle aches and pains and fortemporary increase in circulationto the treated areas in peoplewho are in good health. TheRapid Reboot CompressionTherapy System simulateskneading and stroking of tissuesby using an inflatable garment. | Identical |
| Prescriptive orOTC | OTC | OTC | Identical |
| Environmentof Use | Clinics, hospital, athletetraining, and homeenvironments | Clinics, hospital, athletetraining, and homeenvironments | Identical |
| PowerSource(s) | 15 VDC via in IEC 60601-1compliant power supply(100-240 VAC input),Optional integratedrechargeable battery | 110VAC, 60Hz | Minordifference |
| Weight | 2 kg including battery | 2.63 kg (5.8 pounds) | Minordifference |
| 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") | Minordifference |
| Devicepressure range | 60-150 mmHg | 0-200 mmHg | Pressure rangeof subjectdevice is smallerthan that ofpredicatedevice. |
| TreatmentTime | User can select operationtime among 10, 20, and 30minutes. | User determines therapy time.Choose from 10, 20, or 30minute session time, with optionto add additional 10 minutes toany therapy time. | Identical |
| Number ofinflatableappliancesegments | 6 or less for leg and armcuffs5 or less for hip cuff | 4 | Minordifference |
| Sleeve andchamber | Leg: 6-chambersArm: 6-chambersHip: 5-chambers | Leg: 4-chambersArm: 4-chambersHip: 4-chambers | Minordifference |
| Anatomicalsite | 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 ofcompression | Sequential, Addition, andMassage | Sequential and Peristaltic | Refer to thevisualdescriptionbelow. |
| Mode ofcompression(visualdescription) | SequentialImage: Sequential compression | Mode AImage: Mode A compression | Sequential modeof POWERRECOVERY issimilar to ModeA of thepredicate. |
| AdditionImage: Addition compression | Mode BImage: Mode B compression | Addition modeof POWERRECOVERY issimilar to ModeB of thepredicate. | |
| Massage:Combination ofSEQUENTIAL and Additionmodes | None | Massage modeof POWERRECOVERY isa combinationofSEQUENTIALand Additionmodes. |
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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".
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| ArmImage: Arm sleevesImage: Arm sleeve dimension300x945mm(11.8" x 37.2") | ArmImage: Arm wrapsRegular: 18" x 38"Long: 18" x 44" | Minordifference | |
|---|---|---|---|
| Otheraccessories | Image: AC-DC AdapterAC-DC AdapterImage: Main Hose and Hose AdapterMain Hose Hose AdapterImage: CarrierCarrier | "Not publicly available in theofficial 510K Summary" | Minordifference |
§ 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).