(260 days)
Air Pressure Therapy System (Model:VU-IPC4M) is intended for home to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
Air Pressure Therapy System (Model:VU-IPC4M) consists of air pressure sensor, air pump, sleeves Etc. working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.
The provided document is an FDA 510(k) clearance letter for the Xiamen Weiyou Intelligent Technology Co., Ltd. Air Pressure Therapy System (Model: VU-IPC4M). This letter declares the device substantially equivalent to legally marketed predicate devices.
Crucially, this document is a regulatory clearance and not a detailed study report or clinical trial result. It does not contain information about the specific acceptance criteria for an AI/ML device's performance, nor does it present the results of a study designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.
The "Performance Testing - Clinical" and "Performance Testing - Animal" sections explicitly state "Not Applicable," indicating that the manufacturer did not submit clinical or animal study data to support this 510(k) submission. Therefore, it is impossible to extract the requested information (acceptance criteria, device performance, sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance) for an AI/ML component from this document.
The document focuses on non-clinical performance testing related to the physical device itself and its electrical safety, biocompatibility, and mechanical integrity, as summarized under "Performance Characteristic."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design elements (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth) as they are directly linked to performance evaluation against clinical or diagnostic endpoints, which are not detailed in this regulatory submission.
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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 14, 2024
Xiamen Weiyou Intelligent Technology Co., Ltd. % Libray Chang Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No. 133 Shengang Avenue, Pudong New District Shanghai, 201306 China
Re: K233238
Trade/Device Name: Air Pressure Therapy System (Model: VU-IPC4M) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: May 23, 2024 Received: May 23, 2024
Dear Libray Chang:
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 (QS) 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.
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 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).
Sincerelv.
Heather L. Dean -S
Heather Dean, Ph.D Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
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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
510(k) Number (if known) K233238
Device Name
Air Pressure Therapy System (Model: VU-IPC4M)
Indications for Use (Describe)
Air Pressure Therapy System (Model:VU-IPCAM) is intended for home to temporarily relieve minor muscle aches and or pains, and to temporarily increase circulation to the treated areas in people who are in good health.
| 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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| Type of Submission | Traditional |
|---|---|
| Date Prepared | June 11, 2024 |
| Submission Sponsor | |
| Manufacturer Name | Xiamen Weiyou Intelligent Technology Co., Ltd. |
| Address | Unit 3 No. 6 Xianghong Road, Torch Hi-Tech ZoneIndustrial Park, Xiang'an District, Xiamen P.R.China. |
| Tel | 086-0592-6251545 |
| 17916220@qq.com | |
| Contact Person | Yong Sun |
| Device Identification | |
| Trade Name | Air Pressure Therapy System (Model:VU-IPC4M) |
| Regulation Number | 21 CFR 890.5650 |
| Regulation Name | Powered inflatable tube massager |
| Device Classification | Class II |
| Product Code | IRP |
| Panel | Physical Medicine |
| Application Correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New District, Shanghai, China |
| Tel | 86-13020102321 |
| Libray@spicagloble.com | |
| Contact Person | Libray Chang |
| Indications for Use | |
| Air Pressure Therapy System (Model:VU-IPC4M) is intended for home to temporarily relieve minormuscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who |
Device Description
are in good health.
Air Pressure Therapy System (Model:VU-IPC4M) consists of air pressure sensor, air pump, sleeves
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Etc. working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.
Predicate and Reference Device Information
| Predicate (Primary): | THERAGUN, Inc. |
|---|---|
| Trade/Device Name | RecoveryAir PRO |
| 510(K) number | K211745 |
| Predicate (Secondary): | Wonjin Mulsan Co., Ltd. |
| Trade/Device Name | Compressible Limb and Circulation Therapy System |
| 510(K) number | K211283 |
| Predicate (Tertiary): | SLK Medical GmbH |
| Trade/Device Name | V12 PRO |
| 510(K) number | K210913 |
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
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Table 6A: Summary of Comparison
| Subject Device | Primary Predicate | Secondary Predicate | Tertiary Predicate | DifferencesDiscussion | |
|---|---|---|---|---|---|
| Device name | Air Pressure TherapySystem(Model:VU-IPC4M) | RecoveryAir PRO (ModelRecoveryAir PRO) | Compressible Limb andCirculation Therapy System | V12 PRO | N/A |
| 510(k) number | K233238 | K211745 | K211283 | K210913 | N/A |
| Manufacturer | XiamenWeiyouIntelligent TechnologyCo., Ltd. | Theragun Inc | Wonjin Mulsan Co., Ltd. | SLK MedicalGmbH | N/A |
| Productregulation | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Classificationname | Massager, PoweredInflatable Tube | Massager, Powered InflatableTube | Massager, Powered InflatableTube | Massager, PoweredInflatable Tube | Same |
| Regulation class | 2 | 2 | 2 | 2 | Same |
| Product code | IRP | IRP | IRP | IRP | Same |
| Indications foruse | Air Pressure TherapySystem(Model: VU-IPC4M) isintended for home totemporarily relieveminor muscle achesand/or pains, and totemporarily increase | The RecoveryAir PRO is anair compression therapydevice intended to providegraduated pressure tocompression garments.The RecoveryAir PRO isindicated for the temporaryrelief of minor muscle aches | POWER-Q2300 is intendedfor the temporary relief ofminor muscle aches andpains, and for temporaryincrease in blood circulationto the treated areas in peoplewho are in good health.POWER-Q2300 simulates | V12 PRO is aCompressionTherapy System isintended for thetemporary relief ofminor muscle achesand pains and forthe temporary | Same |
| Rx or OTC | |||||
| circulation to thetreated areas in peoplewho are in good health. | and pains, and for temporaryincrease in blood circulationto the treated areas in peoplewho are in good health.The RecoveryAir PROsimulates kneading andstroking of tissues by usingan inflatable garment. | kneading and stroking oftissues by using an inflatablegarment (cuff). | increase incirculation to thetreated areas inpeople who are ingood health.The V12 PROTherapy Systemsimulates kneadingand stroking oftissues by using aninflatable garment. | Same | |
| Rx or OTC | OTC | OTC | OTC | OTC | Same |
| Power Source | 11.1 V / 1600mAhRechargeable Li-ionbattery (100-240V ACinput) | 100-240V AC, 50/60 Hz,12V or internal battery | 110-120VAC, 50/60Hz | 110-230V 50/60 Hz | Similar |
| Dimensions(WHL) | 25.426.036.92CM | 8.6in (L) *6.7in (W) *5.1in(H) | 290 x 260 x 172 mm | 6.69"x 7.87"x7.87" | Similar |
| Weight | 0.58 kg | 4.202 pounds | 3.1 kg | 4.4 pounds | Similar |
| HousingMaterials | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Molded ABSenclosure | Same |
| Number ofChambers | 4-chamber | 4-chamber | 4 Chambers | 12 Chambers | Similar |
| Sleeve Materials | Nylon cloth +PUetheramine | Polyether Nylon Fabric | / | Nylon with aPolyurethanelaminate | Different |
| Modes | Mode A: In this mode | Sequential, ISO or Rehab | Mode A: | Inflates chambers | Different. |
| ((Inflationsequences)) | (wave), Flow cycles | ||||
| ①chamber is inflatedand the pressure ismaintained after filling;②chambers areinflated, chambers areinflated and ①chamber is deflatedwhile maintainingpressure after filling;Similarly, the pressureis maintained after ③chambers are filled, ④chambers are inflated,and ② chambers aredeflated; Then the cyclerepeats. | Sequential mode that appliesa directional massage,starting at the base of thetreated area, and progressesupwards towards the torsoand then releasesISO mode that applies adirectional massage to asmaller, user selected area.The first chamber inflates,and after a few seconds, thesecond chamber starts toinflate until both chambersreach the set pressure. Thenboth chambers deflate,and after a pause the processstarts againWave mode: The firstchamber inflates, and after afew seconds, the 1st and 2ndchamber starts to inflate untilboth chambersreach the set pressure. Then | Image: Mode B | from bottom up butmaintains pressurein lower chambersas works its way totop. Then allchambers releasepressure at sametime once allchambers havesequentiallyinflated.Sequential | Although thesubject deviceprovides 7 kindsof work mode,the Mode A andMode B are thesame withSequential, ISOor Rehab (wave)of Primarypredicate device(K211745), whilethe other workmodes of subjectdevice just havedifference aboutinflatable order ofthe differentchambers. Thetreatmentpressure range arethe same underdifferent workmodes, so thedifference ofpressure rangewould not raise | |
| Mode B: In this mode,①chamber is inflatedand the pressure ismaintained after filling;②chamber inflation;the same as ③chamberand ④chamber; Thenthe cycle repeats. | Image: Mode C | ||||
| Mode C: In this mode, | Image: Mode D |
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| the four chambers are | the deflation on 1st chamber , | adversely impact | |
|---|---|---|---|
| inflated at the same | the 2nd and 3rd chambers | on safety and | |
| time, the pressure is | starts to inflate until the both | effectiveness. | |
| maintained after filling, | chambers reach the set | ||
| and then the four | pressure; then deflate the 2nd | ||
| chambers are deflated | chambers inflate 3rd and 4th | ||
| at the same time;After | chambers until the both | ||
| deflation, the four | chambers reach the set | ||
| pressure | |||
| chambers are inflated at | |||
| the same time;Then the | Flow cycles | ||
| cycle repeats. | Progress 1: first inflate | ||
| Chamber 1 to target pressure,then hold & release. then goto Progress 2. | |||
| Mode D: In this mode, | Progress 2: first inflated | ||
| only a single chamber | Chamber 1 to target pressure, | ||
| is inflated at a time. | theninflate Chamber 2 and | ||
| Starting from the | hold Chamber 1. when | ||
| chamber① and | Chamber 2 reach the target | ||
| working up to the | pressure, hold chamber 1 & 2 | ||
| chamber④. Then the | for specified time, then | ||
| cycle repeats. | release totally, then go to | ||
| Progress 3 | |||
| Mode E: in this mode. | Progress 3: first inflated | ||
| ①③are inflated,then | Chamber 1 to target pressure, | ||
| defalted, chamber ② | then inflate Chamber 2 and | ||
| ④are inflated,then | |||
| deflated;Then the cycle | |||
| repeats. | |||
| Mode F: in this mode. | hold Chamber 1. when | ||
| ①② are inflated, then | Chamber 2 reach the target | ||
| defalted, chamber ③ | pressure, hold chamber 1 & | ||
| ④ are inflated, then | 2, & start to inflate | ||
| deflated; Then the cycle | Chamber 3, when Chamber 3 | ||
| repeats. | reach to the target pressure, | ||
| then hold chamber 1, 2, 3 for | |||
| specified time then release | |||
| ModeG: In this mode, | totally. Then go to Progress 4 | ||
| chamber 1 inflates to | Progress 4: first inflated | ||
| set pressure, it pulses | Chamber 1 to target pressure, | ||
| and holds pressure; | then inflate Chamber 2 and | ||
| Chamber 2 inflates to | hold Chamber 1. when | ||
| set pressure, pulses and | Chamber 2 reach the target | ||
| holds pressure, | pressure, hold chamber 1 & | ||
| chamber 1 is holding | 2, & start to inflate | ||
| pressure at the same | Chamber 3, when Chamber 3 | ||
| time; Chamber 3 | reach to the target pressure, | ||
| inflates to set pressure, | then hold chamber 1, 2, 3,& | ||
| pulses and holds | start to inflate Chamber 4, | ||
| pressure, chamber 1 & | when Chamber 4 reach to the | ||
| 2 are holding pressure | target pressure, then hold | ||
| at the same time; While | chamber 1, 2, | ||
| chamber 1 is | 3 &4 for specified time then | ||
| deflating, chamber 4 | release totally. then go back | ||
| inflates to set pressure, | to Progress 1 again. | ||
| pulses and holds |
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Image /page/11/Figure/3 description: The image shows different modes of operation for a compression device. The modes include sequential cycle mode, sequential rehab (wave), wave cycle mode, and ISO cycle mode. The image also shows different programs (A, B, D, E, and F) with different patterns of chamber inflation and deflation.
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| Flow cycles | |||||
|---|---|---|---|---|---|
| Image: Flow cycle mode | |||||
| Anatomical site | Leg (including of foot,calf, knee, upper leg)Pants (including ofupper leg, glutes, hips,lower back)Arm (including ofentire arm, shoulder)Half-Leg (including offoot, calf, knee) | RecoveryAir CompressionBoots: 95*28.7 cm | Leg (including of foot, calf,knee, upper leg)Hip (including of upper leg,glutes, hips, lower back)Arm (including of entire arm,shoulder)Half-Leg (including of foot,calf, knee) | Leg (consisting offoot, calf, knee,upper leg) Pant(consists of foot,calf, knee, upperleg, glutes, hips,lower back)Arm (consisting ofentire arm,shoulder, upperchest and back)Jacket (consisting ofentire arms,shoulder, upperchest andback) | Similar |
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510(k) Summary K233238
Image /page/13/Figure/1 description: The image shows a comparison of different types of compression cuffs and pants. On the left, there are two sets of leg cuffs and a pair of pants, labeled with "Appearance and size of Cuffs". In the middle, there is a leg cuff with dimensions "Medium: 310x940mm" and "Large: 390x990", along with measurements of 310 and 940. On the right, there is a leg cuff with dimensions "32" x 30"", a pant, and the word "Similar".
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Image /page/14/Figure/1 description: The image shows a collection of medical compression garments. There are pants, arm sleeves, a waist wrap, hip wraps, and a jacket. Some of the items have dimensions listed, such as the arm sleeves which are available in medium (255x870mm) and large (330x895mm).
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| Image: black sleeve | Half-LegImage: Half-Leg device with dimensions 300 and 700300x700mm | ||||
|---|---|---|---|---|---|
| Device Pressure range | 30~180mmHg | 20-100mmHg | 20-200 mmHg | 15-80 mmHg | Similar toK211283,Although thepressure value isdifferent fromthat of thePrimary Predicateand TertiaryPredicate, it isincluded in thepressure valuerange of theSecondary |
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| Predicate, so thepressure value ofthe SubjectDevice can beproven to notaffect its safetyand effectiveness | |||||||
|---|---|---|---|---|---|---|---|
| Treatment Time | DefaultSettings | 30min, APP | 10min-90min, step of 5min | User can select operationtime from 15 and 30 minutes. | User determinestherapy time. Choosefrom 15 to 60minutessessiontime. | Different,Although thetreatment timerange of subjectdevice is set byAPP, but thedefault value is30min which isincluded in therange of thecomparisonequipment. In theprocess of use,the user can startor stop the buttonon the handcontroller at anytime, so thedifference ofTreatment time |
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| would not raiseadversely impacton safety andeffectiveness. | |||||
|---|---|---|---|---|---|
| Hold time withincycle | 30-180 sec | 2-10 sec. | 1 min 20 sec | 1 min 15 sec | Similar |
| Pause interval -between cycles | 15 sec | 10 - 70 sec | Adjustable at interval of0/5/10/30 sec at modes A andBFixed at 30 sec at modes Cand D | / | Similar |
| Mobileapplication | Bluetoothcommunication | Bluetooth communication | / | / | Same |
| Patient contact | Non-conductiveappliances | Non-conductive appliances | / | / | Same |
| Software/Firmware/Microprocessor Control | Microprocessor | Microprocessor | / | Firmware/Microprocessor | Similar |
| Technology | Compressor and valvesystem whichsequentially inflatesinflatable chambers | Compressor and valve systemwhich sequentially inflatescells of appliance | Compressor and valvesystem which sequentiallyinflates cells of appliance | Compressorandvalve system whichsequentially inflatescells sequentially | Same |
| Electrical safetyEMC | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1:2005;IEC 60601-1-2:2014;IEC60601-1-11:2015 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993 | Same |
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Performance Characteristic
The device meets all the applicable technical requirements of :
IEC 60601-1:2005 - Medical electrical equipments - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11: 2015 - Medical electrical equipments for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2: 2014 - Medical electrical equipments for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility
IEC 62133-2: 2017 - 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
ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-5:2009 - Biological Evaluation of Medical Device - Part 5: Tests for in vitro Cytotoxicity
IEEE ANSI USEMCSC C63.27-2021-American National Standard for Evaluation of Wireless Coexistence
Software Verification and Validation Testing
The device also passed:
- pressure accuracy and time accuracy testing i.
- ii. seam strength testing to ensure cuffs do not burst if maximum pressure is exceeded
- iii. failure mode verification and validation testing to ensure mitigation of overpressurization risk if there is a software failure
Conclusion
Based on the indications for use, technological characterstics, and non-clinical performance data, "Air Pressure Therapy " is as safe, as effective, and performs as well as the legally marketed predices. Therefore, the substantially equivalent to the 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).