Air Pressure Therapy System

K201935 · Xiamen Weiyou Intelligent Technology Co., Ltd. · IRP · Jun 22, 2021 · Physical Medicine

Device Facts

• Record ID: K201935
• Device Name: Air Pressure Therapy System
• Applicant: Xiamen Weiyou Intelligent Technology Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jun 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Air Pressure Therapy System VU-IPC04B is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Device Story

Air Pressure Therapy System VU-IPC04B is an intermittent pneumatic compression device consisting of a pump unit connected to a multi-chambered cuff (6 chambers) via hoses. The pump inflates and deflates chambers in specific sequences to provide compression from the body's distal end toward the center. Operated by the user in home or rehabilitation settings, the device allows adjustment of cycle time and pressure to ensure comfort. The system provides four distinct compression modes (A, B, C, D) to facilitate muscle relaxation and circulation. By applying sequential pressure, the device aims to relieve muscle soreness and improve blood flow, aiding in recovery and rehabilitation.

Clinical Evidence

No clinical data. Bench testing only. Device performance verified through electrical safety, electromagnetic compatibility, and biocompatibility testing (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Molded ABS enclosure; 6-chamber inflatable cuff; compressor and valve system; pressure range 30-110mmHg; power 110-240V, 50/60Hz; dimensions 22x14x9cm; weight 1.6kg. Standards: IEC 60601-1-11, IEC 60601-1-2, ANSI AAMI ES60601-1, ISO 10993-5, ISO 10993-10, IEC 62133-2.

Indications for Use

Indicated for individuals seeking temporary relief of minor muscle aches and/or pains and temporary increase in circulation to treated areas. Suitable for home use for circulation improvement and exercise rehabilitation settings for pre-exercise muscle relaxation and post-exercise muscle soreness relief.

Regulatory Classification

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.

Predicate Devices

• NormaTec Pulse and NormaTec Pulse Pro (K160608)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 22, 2021

Xiamen Weiyou Intelligent Technology Co., Ltd % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai. 201306 China

Re: K201935

Trade/Device Name: Air Pressure Therapy System: VU-IPC04B Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: February 3, 2021 Received: June 2, 2021

Dear Sam Lin:

We have reviewed vour 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director. Acute Injurv 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

510(k) Number (if known) K201935

Device Name

Air Pressure Therapy System: VU-IPC04B

Indications for Use (Describe)

Air Pressure Therapy System VU-IPC04B is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

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 | February 3, 2021 |
| Submission sponsor | |
| Manufacturer name | Xiamen Weiyou Intelligent Technology Co., Ltd. |
| Address | Unit 101-401, No.6 Xianghong Road, Xiang'an District, Xiamen,<br>Fujian, China |
| Tel | 86-0592-6251545 |
| Email | [e-mail] |
| Contact person | Yong Sun |
| Device identification | |
| Classification name | Massager, Powered Inflatable Tube |
| Trade name | Air Pressure Therapy System: VU-IPC04B |
| Device classification | Class II |
| Regulation number | 21 CFR 890.5650 |
| Panel | Physical Medicine |
| Product code | IRP |
| Previous submissions | None |
| Application correspondent | |
| Company name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New District,<br>Shanghai, China |
| Tel | 86-15626132181 |
| Email | [e-mail] |
| Contact person | Sam Lin |
| Predicate and reference device information | |
| | |

| Sponsor | NORMATEC INDUSTRIES, LP X |
|-------------------|---------------------------------------|
| Trade/Device name | NormaTec Pulse and NormaTec Pulse Pro |
| 510K number | K160608 |
| Regulation number | 21 CFR 890.5650 |

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### Indications for use of the device

Air Pressure Therapy System VU-IPC04B is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

### Device description

Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 6 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process. Cycle time and pressure can be adjusted by purpose to avoid any discomfort.

Air Pressure Therapy System intermittent pneumatic compression could be used in family for improving blood circulation in the treated area, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.

### Performance testing - clinical

Not Applicable.

### Performance testing - animal

Not Applicable.

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| | Subject device | Predicate device | Differences discussion | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device name | Air Pressure Therapy System: VU-IPC04B | NormaTec Pulse and NormaTec Pulse<br>Pro | | |
| 510(k) number | K201935 | K160608 | N/A | |
| Manufacturer | Xiamen Weiyou Intelligent Technology Co., Ltd. | NORMATEC INDUSTRIES, LP X | N/A | |
| Product regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same | |
| Classification name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same | |
| Regulation class | 2 | 2 | Same | |
| Product code | IRP | IRP | Same | |
| Indications for use | Air Pressure Therapy System VU-IPC04B is<br>intended to temporarily relieve minor muscle aches<br>and/or pains, and to temporarily increase circulation<br>to the treated areas. | The NormaTec Pulse and Pulse Pro is<br>an air pressure massager intended to<br>temporarily relieve minor muscle<br>aches and/or pains, and to temporarily<br>increase circulation to the treated<br>areas. | Same | |
| Rx or OTC | OTC | OTC | Same | |
| Pressure range | 30-110mmHg | 30-110mmHg | Same | |
| Treatment time | 5-99mins | Stays on until the user turns it off or<br>can be set up to turn off in a range of<br>10 mins to continuous / User<br>controlled 10 minutes to 175 minutes<br>or continuous -total time over 4 | Similar<br>The treatment time of subject<br>device is smaller than<br>predicate device (K160608)<br>so the difference of treatment | |
| | | | | |
| | | segments. | time would not raise adversely<br>impact on safety and<br>effectiveness. | |
| Standard | IEC 60601-1-11,<br>ES60601-1:2005/(R)2012<br>C1:2009/(R)2012 and<br>60601-1-2, ISO 10993-10,<br>62133-2 | ANSI AAMI A1:2012,<br>and A2:2010/(R)2012, IEC<br>ISO 10993-5, IEC | ES 60601-1, IEC 60601-1-2, IEC<br>60601-1-11 | Similar |
| Mode of compression | Sequential | Sequential | Same | |
| Power source | 110-240V; 50Hz/60Hz | 100- 240 VAC input | Similar | |
| Power consumption | 35W | 14W | Similar | |
| Dimensions(W*H*D) | 22*14*9CM | 4" x 5" x 9" | Similar | |
| Weight | 1.6KG | 3.6 pounds | Similar | |
| Photo | Image: a black device with buttons | N/A | Similar | |
| Size and appearance of<br>sleeves (leg part) | Image: two black sleeves and a black round object<br>M: 91x65cm<br>XL: 110x70cm(overlapping)<br>XXL: 125x76cm(overlapping) | Short: 14" x 43"<br>Standard: 14" x 48"<br>Tall: 14" x 60" | Similar | |
| Housing materials | Molded ABS enclosure | Molded ABS enclosure | Same | |
| Number of chambers | 6 chambers | 5 chambers | Similar | |
| | Mode A: | Sequential mode: | Although the subject device | |
| | In this mode, only a single chamber is inflated at a<br>time. Starting from the chamber ① and working up | Starting with the distal chamber and | provides 4 kinds of work | |
| | to the chamber ⑥. Then the cycle repeats. | progressing up the proximal chamber, | mode, the Mode A and Mode | |
| | Mode B: | each section compresses and the | C are the same with predicate | |
| | In this mode, the chamber ① stays inflated. It | pressure gradually rises to the | device (K160608), while the | |
| | gradually adds a chamber until all six chambers are | pre-determined air pressure level, | other work modes of subject | |
| | filled with air. Then the cycle repeats. | then decompresses and the air<br>pressure drops. | device just have difference | |
| | Mode C: | Once the top section decompresses,<br>the cycle begins again. again. | about inflatable order of the | |
|…