(238 days)
Air Compression Leg 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. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.
Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.
Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.
Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.
The provided text does not contain detailed information about acceptance criteria for device performance or a study that specifically proves the device meets those criteria. The document is a 510(k) summary for an Air Compression Leg Massager, primarily focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results for the subject device.
The "Performance Data" section (VIII) lists several non-clinical tests performed to support the substantial equivalence determination, but these are primarily related to safety, electromagnetic compatibility, battery safety, and software validation, not the direct clinical performance of improving circulation or relieving aches and pains.
Therefore, many of the requested details cannot be extracted from this document. However, I can summarize what is present:
What is present in the document:
- Non-clinical tests performed: Biocompatibility, Electrical Safety and EMC, Battery Safety, and Software Verification and Validation.
- Result of these tests: They "passed" or "demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels."
- Overall Conclusion: The device is considered "as safe, as effective, and performs as well as the primary predicate device and secondary predicate device" based on this analysis and non-clinical tests.
What is NOT present in the document (and thus cannot be filled in):
- A table of acceptance criteria and reported device performance for clinical effectiveness (e.g., specific metrics for pain relief or circulation increase).
- Sample size used for a performance test set.
- Data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.
- Number of experts used or their qualifications for establishing ground truth (as no clinical performance study is detailed).
- Adjudication method for a test set.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
- Information on a standalone (algorithm only) performance study.
- The type of ground truth used for clinical performance.
- The sample size for the training set (as it's a physical device, not an AI/ML algorithm that requires a training set in the described sense).
- How the ground truth for the training set was established.
Based on the available information, here's a summary of the compliance for the listed non-clinical tests:
| Test Category | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance and Conclusion |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation) indicating the body-contacting materials (Nylon polyester for leg wraps, ABS, PC for enclosure) are safe for intended contact. This implies non-toxic, non-irritating, and non-sensitizing properties. | "The following testing was performed to, and passed, including: ISO 10993-5, ISO 10993-10, ISO 10993-23." This confirms the device meets the biocompatibility requirements. |
| Electrical Safety and EMC | Compliance with IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances - requirements and tests), and IEC 60601-1-11 (requirements for home healthcare environment). This implies the device safely operates electrically, does not interfere with other devices, and is safe for home use. | "Electrical safety and EMC testing was performed to, and passed, the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11." This confirms compliance with international safety and EMC standards. |
| Battery Safety | Compliance with IEC 62133-2 (safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems). This implies the internal lithium battery meets safety standards to prevent hazards like overheating, fire, or explosion. | The testing for IEC 62133-2 was performed and passed, implying the battery components are safe. |
| Software Verification and Validation | Basic documentation consistent with 510(k) requirements. System validation testing to demonstrate that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. This implies the software (firmware/microprocessor control) functions as intended and is free from critical defects that could pose a safety risk. | "Software documentation consistent with basic documentation this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This confirms the software's functional and safety integrity as per the established requirements. |
Study that proves the device meets the acceptance criteria:
The document states that the substantial equivalence determination is supported by these non-clinical performance data. It does not describe a clinical study measuring the device's efficacy in achieving "temporary relief of minor muscle aches and pains" or "temporary increase in circulation," as the FDA often relies on technological similarity to a predicate device for this type of claim, assuming the predicate's effectiveness. The listed tests are primarily aimed at ensuring the device's safety and fundamental operational integrity as an inflatable tube massager.
Therefore, for the clinical performance claims (pain relief, circulation increase), the "study" is implicitly the demonstration of substantial equivalence to already cleared predicate devices that have established these claims, rather than a de novo clinical trial with specific clinical acceptance criteria for the subject device.
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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 17, 2025
Jiale Health Technology Shenzhen Co., Ltd. % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K242140
Trade/Device Name: Air Compression Leg Massager (K-705) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IRO Dated: January 15, 2025 Received: February 26, 2025
Dear Youshan Gong:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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
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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 L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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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| Indications for Use | |
|---|---|
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K242140 |
| ? | |
| Please provide the device trade name(s). | |
| Air Compression Leg Massager (K-705) | |
| ? | |
| Please provide your Indications for Use below. | |
| Air Compression Leg 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. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment. | |
| ? | |
| Please select the types of uses (select one or both, as applicable). | Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ? |
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510(k) Summary K242140
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: 2025-3-11
I. Submitter
Jiale Health Technology Shenzhen Co., Ltd. 201, Builing A, No, 17, Guangjin Road, Shapu Community, Songgang Street, Bao 'an District, Shenzhen, China Post code: 518100 Tel.: 0755-27085534
XieLixun General Manager Tel: +86-13823109212 E-mail: 402952497@qq.com
II. Device
Name of Device: Air Compression Leg Massager Model(s): K-705 Common or Usual Name: Massager, Powered Inflatable Tube Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP, IRO Regulation Number: 21 CFR 890.5650, 21 CFR 890.5975
III. Predicate Device and Reference Device
- Predicate Device A
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| Manufacturer | Predicate Device | 510(k) Number |
|---|---|---|
| Xiamen EmokaHealthScience&Technology Co., Ltd. | Air Compression LegMassager (model: EMK-701) | K222991 |
Secondary Predicate Device A
| Manufacturer | Reference Device | 510(k) Number |
|---|---|---|
| THERABODY, Inc | JetBoots PRO Plus | K241256 |
IV. Device Description
Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller.
Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug.
Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance.
Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.
V. Indications for Use
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Air Compression Leg 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. Air Compression Leg Massager simulates kneading of tissues by using an inflatable garment.
VI. Materials
| Model | Contacted Component Name | Materials |
|---|---|---|
| K-705 | Leg wraps | Nylon polyester |
| Enclosure of Controller | ABS, PC |
VII. Comparison of Technological Characteristics With the Predicate Device
The Air Compression Leg Massager (K-705) has the same intended use as the predicate devices . The technological characteristics such as application area, number of chambers, ar pressure level and treatment time, are similar to the primary predicate device. Any minor differences between the listed primary predicate device and secondary predicate device do no raise any issues of safety or efficacy. Performance data supports that the device is the primary predicate device and secondary predicate device for its intended use.
Therefore, the Air Compression Leg Massager may be found substantially equivalent to its primary predicate device.
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---|---|---|---|---|
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| 510(k) Number | K242140 | K222991 | K241256 | / |
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| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---|---|---|---|---|
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Trade name | Air Compression LegMassager | Air Compression LegMassager (model: EMK-701) | JetBoots PRO Plus | / |
| Manufacturer | Jiale Health TechnologyShenzhen Co., Ltd. | Xiamen EmokaHealthScience&Technology Co., Ltd. | THERABODY, Inc | / |
| Regulation number | 21 CFR 890.565021 CFR 890.5975 | 21 CFR 890.565021 CFR 890.5975 | 21 CFR 890.565021 CFR 890.550021 CFR 890.5975 | Same |
| Device class | II | II | II | Same |
| Product code | IRP, IRO | IRP | IRP, ILY, IRO | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Indication for use | Air Compression LegMassager is indicated for thetemporary relief of minormuscle aches and pains andfor temporary increase incirculation to the treated areasin people who are in goodhealth. Air Compression LegMassager simulates kneadingand stroking of tissues byusing an inflatable garment. | Air Compression LegMassager is indicated forthe temporary relief ofminor muscle aches andpains and for temporaryincrease in circulation to thetreated areas in people whoare in good health. AirCompression Leg Massagersimulates kneading andstroking of tissues by usingan inflatable garment. | JetBoots PRO Plus is an aircompression therapy deviceintended to provide graduatedpressure to the legs. JetBoots PROPlus is indicated for the temporaryrelief of minor muscle aches andpains, and for a temporary increasein blood circulation to the treatedarea in people who are in goodhealth. JetBoots PRO Plussimulates kneading and stroking oftissues by using an inflatablegarment. | Same |
| Prescription or OTC | Over-The-Counter Use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Power Source | Input: AC100-240V,50/60HZOutput: DC5V/1AInternal battery: 3.7V2500mAh | Input: AC100-240V,50/60HzOutput: DC 13.5V, 1AInternal battery:11.1V,1000mAh | Power Adapter:AC Input: 100 -240V AC,50/60Hz, DC Output: 15.0V, 4.8A,72WOrInternal Battery | Different |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Powerconsumption | 6.5W | 13.5 W | 72WOrInternal Battery | Different |
| Dimensions (WHD) | 35817267mm | 2155070 mm | Console & Compression boot (Leador Support, deflated and fullyextended):• S-size: 36.8in (L) * 5.3in (W) *14.8 (H)• M-size: 42.9in (L) * 5.3in (W) *16.1 (H)• L-size: 46.5in (L) * 5.3in (W) *16.1 (H) | Different |
| Weight | 0.59kg(1.28pounds) | 2.0 Kg (4.4pounds) | S-size: 6.0lb (per boot)M-size: 6.4lb (per boot)L-size: 6.7lb (per boot) | Different |
| HousingMaterials | Molded ABS enclosure | Molded ABS enclosure | Molded PC+ABS enclosure | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Sleeves Dimensions | Leg Wrap: 350*628mm | Leg Wrap: 730*468 mm | Compression boots sleeves attached to consoles.Sleeves (extended) only:S: 80cm (L)* 37.5 cm (H)M: 95cm (L)* 41.0 cm (H)L: 1050cm (L)* 41.0 cm (H) | Different |
| Application area | Leg (calves) | Leg (feet, calves) | Leg (feet, calve) | Different |
| Number of Chambers | 2-chamber | 2-chamber | 4-chamber | Different |
| Sleeve Materials | Nylon polyester | Dacron | Polyether Nylon Fabric | Different |
| Mode of Compression | Sequential | Sequential | No related information | Same |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Air PressureLevel | Low level: 120mmHgMedium level: 170mmHgHigh level: 210mmHgError range: ±25mmHg | Low level: 120mmHgMedium level: 170mmHgHigh level: 210mmHgError range: ±25mmHg | 20 – 100 mmHg, steps of 5mm Hg | Same |
| Treatment Time | 15 minutes | 15 minutes | 10min – 60min, steps of 5min forPneumatic Compression10min – 45min for Infrared LED | Same |
| Inflation time | 2-12s | 5 -18 s | No related information | Different |
| Keep time | 3-6s | 2 - 5 s | 0 – 10 seconds depending on theselected preset. | |
| Deflation time | 1-6s | 2 - 5 s | No related information | |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Cycle time | Range of 6sec to 1 min 2.0sec | Range of 26 sec to 1 min 29sec | Pause interval between cycles: 15seconds | |
| Work Mode | The model is divided intothree processes.Mode 1: The upper leg airbag is pressurized, then thelower air bag is pressurized,and then the pressure isrelieved, and then the aboveprocess is repeated. Then theupper and lower is pressurizedat the same time, and then thestatic pressure is maintained.And then the cycle isrepeated.The air pressure of Mode 1 is120mmHg. | Mode 1:The model is divided intothree processes. The firstprocess is starting w ith footchamber inflates and holdsthe air until the calfchamber is compressed.Then deflatessimultaneously. The secondprocess is starting with footchamber inflates and holdsthe air until the calfchamber is compressed.Then calf chamber deflates,and finally foot chamberdeflates. The third process isstarting with calf chamber | Sequential, ISO, or Static FlowCyclesSequential mode that applies adirectional massage, starting at thebase of thetreated area, and progressesupwards towards the torso and thenreleases.Image: Sequential cycle mode | Different |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Image: foot diagramImage: foot diagramMode 2: The lower air bag ispressurized→ pressureretention → pressure→pressure retention →pressurerelief. And then the cycle isrepeated.The air pressure of Mode 2 is170mmHg.Image: foot diagramImage: foot diagramMode 3: The upper and lowerpressure is pressurized at thesame time →The upperpressure → pressure relief.And then the cycle isrepeated. | Mode 1 follow s thispressure sequence: Foot →Foot + Calf→ Interval →Foot → Foot +Calf → Foot→ Interval → CalfMode 2:In this model, foot chamberand calf chamber areinflated and deflated at thesame time.Mode 2 follow s thispressure sequence: Foot +Calf → Interval → Foot+CalfThe inflating and deflatingtime are different accordingto the intensity selected. | massage to a smaller, user- selectedarea.The first chamber inflates, and aftera few seconds, the second chamberstarts to inflate until both chambersreach the set pressure. Then bothchambersdeflate, and after a pause theprocess starts again.Image: ISD cycle mode diagramFlow cycles Progress 1: first inflateChamber 1 to target pressure, thenhold &release, then go to Progress 2. | ||
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| The air pressure of Mode 3 is210mmHg.Image: diagram of air pressure | Progress 2: first inflated Chamber 1to target pressure, then inflateChamber 2 and hold Chamber 1.when Chamber 2 reach the targetpressure, hold chamber 1 & 2 forspecified time, then release totally,then go to Progress 3 Progress 3:first inflated Chamber 1 to targetpressure, then inflate Chamber 2and hold Chamber 1. whenChamber 2 reach the targetpressure, hold chamber 1 & 2, &start to inflate Chamber 3, whenChamber 3 reach to the targetpressure, then hold chamber 1, 2, 3for specified time then releasetotally. then go to Progress4.Progress 4: first inflated Chamber1 totarget pressure, then inflateChamber 2 and hold Chamber 1.when Chamber 2reach the target pressure, hold | |||
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Chamber 3, when Chamber 3 reachto the target pressure, then holdchamber 1, 2, 3,& start to inflateChamber 4, when Chamber 4 reachto the target pressure, then holdchamber 1, 2, 3 &4 for specifiedtime then release totally. then goback to Progress 1 again.Image: Static Cycle diagramStatic CycleThe chambers inflate one at thetime starting at chamber 1 whilemaintainingnegative gradient of compressionalong the leg. The pressure islimited to 20mmHg to 30 mmHg. Once inflated,the chambers do not deflate during | ||||
| Comparison Elements | Subiect Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| thetreatment. While the garment isinflated, it comes in contact withthe legs to optimize the treatment ofvibration and infrared LED light byensuring optimal contact with theleg. | ||||
| Noise level | ≤ 65 dB | ≤ 65 dB | No related information | Same |
| Patient contact | Non-conductive appliances | Non-conductive appliances | Non-conductive appliances | Same |
| Softw are/Firmware/MicroprocessorControl | Microprocessor | Microprocessor | Microprocessor | Same |
| Technology | Compressor and valve systemwhich sequentially inflatescells of appliance | Compressor and valvesystem which sequentiallyinflates cells of appliance | Compressor and valve systemwhich sequentially inflates cells ofappliance,Light Emitting Diodes | Same |
| Safety Features | Power button allows user tostop therapy session at anytime | Power button allows user tostop therapy session at anytime | No related information | Same |
| Comparison Elements | Subiect Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| Operatingenvironment | Temperature: 5°C-35°CHumidity: 5%- 90% non-condensingAtmospheric Pressure: 75-106kPa | Temperature: 5°C-40°CHumidity: 5%- 90% noncondensing | No related information | Same |
| Transportation &Storageenvironment | Temperature: -20°C~55°CHumidity: 5%-90% noncondensingAtmospheric Pressure: 75-106kPa | Temperature: -20°C~55°CHumidity: 5%-90% noncondensingAtmospheric Pressure: 75-106kPa | No related information | Same |
| Level of heating | Low temperature: 35°CMedium temperature: 38°CHigh temperature: 41°CError range: ±2°C | N/A | Maximum Device SurfaceTemperature: 43.2°CHighest Measured SkinTemperature During Treatment:36.8° C | Different |
| Level of vibrationfrequency | Constant frequency150Hz(±15Hz)Low level: 1 second on, 3seconds offMid level: 1 second on, 2 | N/A | No related information | Different |
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Model | K-705 | EMK-701 | JetBoots PRO Plus | / |
| seconds offHigh level: 0.5 second on, 0.5seconds off | ||||
| Electrical safety, EMC | IEC 60601-1IEC 60601-1-2IEC 62133-2IEC 60601-1-11 | ANSI/AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 61233 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5 ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
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Conclusions
Air Compression Leg Massage is substantially equivalent to the primary predicate device and secondary predicate device.
VIII. Performance Data
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The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the subject device was conducted in accordance with the "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Nanagement Process", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for skin sensitization
-
ISO 10993-23, Biological evaluation of medical devices Part 23: Tests for skin irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
-
IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Medical electrical equipments Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
IEC 60601-1-11 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
3) Battery Safety
-
IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
4) Software Verification and Validation
Software documentation consistent with basic documentation this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
IX. Conclusions
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Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Air Compression Leg Massager is as safe, as effective, and performs as well as the primary predicate device and secondary predicate device.
§ 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).