(41 days)
Not Found
No
The description focuses on mechanical compression and pressure adjustment, with no mention of AI/ML terms or functionalities.
Yes
The device is intended to temporarily relieve minor muscle aches and/or pains and temporarily increase circulation, which are therapeutic claims.
No
The intended use explicitly states the device is for temporary relief of minor muscle aches/pains and to temporarily increase circulation, not for diagnosing any condition.
No
The device description explicitly states it has a "pump" and "cuff via the hose series," which are hardware components. The description focuses on the mechanical action of air compression and inflation, not solely on software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas." This describes a therapeutic or physical therapy application, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device description details a system that applies external air pressure to the body via cuffs. This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Air Pressure Therapy System VU-IPC06 is intended for home to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.
Product codes
IRP
Device Description
Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 8 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 treated areas, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
NOT Applicable.
NOT Applicable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 11, 2021
Xiamen Weiyou Intelligent Technology Co., Ltd. % Sam Lin Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai, 201306 China
Re: K210967
Trade/Device Name: Air Pressure Therapy System: VU-IPC06 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: December 7, 2020 Received: March 31, 2021
Dear Sam Lin:
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 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
1
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 medical devices and radiation-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 Device Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210967
Device Name Air Pressure Therapy System VU-IPC06
Indications for Use (Describe)
Air Pressure Therapy System VU-IPC06 is intended for home to temporarily relieve minor muscle aches 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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3
K210967: 510(K) Summary
| Type of Submission | Traditional |
|---|---|
| Date Prepared | December 7, 2020 |
| Submission Sponsor | |
| Manufacturer Name | Xiamen Weiyou Intelligent Technology Co., Ltd. |
| Address | Unit 101-401, No.6 Xianghong Road, Xiang'an District, Xiamen, Fujian, China |
| Tel | 086-0592-6251545 |
| 17916220@qq.com | |
| Contact Person | Yong Sun |
| Device Identification | |
| Classification Name | Massager, Powered Inflatable Tube |
| Trade Name | Air Pressure Therapy System: VU-IPC06 |
| 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, Shanghai, China |
| Tel | 86-15626132181 |
| sam@spicagloble.com | |
| Contact Person | Sam Lin |
| Predicate and Reference Device Information |
| Sponsor | NormaTec Industries, LP |
|---|---|
| Trade/Device Name | NormaTec Pulse and NormaTec Pulse Pro |
| 510(K) number | K160608 |
| Regulation Number | 21 CFR 890.5650 |
4
Indications for Use of the Device
Air Pressure Therapy System VU-IPC06 is intended for home 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 8 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 treated areas, 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.
[Remainder of page left intentionally blank]
5
| Subject Device | Predicate Device | Differences Discussion | |
|---|---|---|---|
| Device name | Air Pressure Therapy System: VU-IPC06 | NormaTec Pulse and NormaTec Pulse | |
| Pro | N/A | ||
| 510(k) number | K210967 | K160608 | N/A |
| Manufacturer | Xiamen Weiyou Intelligent Technology Co., Ltd. | NormaTec Industries, LP | 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-IPC06 is intended for | ||
| home to temporarily relieve minor muscle aches and/or | |||
| pains, and to temporarily increase circulation to the | |||
| treated areas. | The NormaTec Pulse and Pulse Pro is an | ||
| air pressure massager intended to | |||
| temporarily relieve minor muscle aches | |||
| and/or pains, and to temporarily increase | |||
| circulation to the treated areas. | Same | ||
| Rx or OTC | OTC | OTC | Same |
| Pressure range | 30-110mmHg | 30-110mmHg | Same |
| Treatment time | 1-99min | Stays on until the user turns it off or can | |
| be set up to turn off in a range of 10 | |||
| mins to continuous / User controlled 10 | |||
| minutes to 175 minutes or continuous | |||
| -total time over 4 segments. | Similar | ||
| The treatment time of | |||
| subject device is smaller | |||
| than predicate device | |||
| (K160608), so the | |||
| difference of treatment | |||
| time would not raise | |||
| adversely impact or | |||
| safety and effectiveness. | |||
| Standard | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, | ||
| C1:2009/(R)2012 and A2:2010/(R)2012 | |||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | |||
| ISO 10993-5 | |||
| ISO 10993-10 | ES 60601-1, | ||
| IEC 60601-1-2, | |||
| IEC 60601-1-11 | Similar | ||
| Mode of compression | Sequential | Sequential Gradient, Peristaltic and | |
| Pulsing | Same | ||
| Power source | 110-120V, 50/60Hz | 12 VDC via an IEC 60601-1 compliant | |
| power supply (100-240 VAC input) | |||
| Optional Integrated rechargeable battery | Similar | ||
| Power consumption | 65VA | 14W | Similar |
| Dimensions (WHD) | 3023.712.6CM | 4" x 5" x 9" | Similar |
| Photo | Image: a white device with a screen | Image: a black device with a screen | Similar |
| Size and appearance | |||
| of sleeves (leg part) | Image: a blue leg sleeve | ||
| Leg sleeve: | |||
| M: 91*65cm | Image: a black leg sleeve | ||
| Short: 14" x 43" | |||
| Standard: 14" x 48" | Similar | ||
| L: 100*74cm | |||
| XL: 110*70cm (overlapping) | Tall: 14" x 60" | ||
| Housing materials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number of chambers | 8 Chambers | 5 or less | Similar |
| Work mode | Image: work_mode_8_chambers | Sequential mode: | |
| Starting with the distal chamber and | |||
| progressing up the proximal chamber, each section compresses and the pressure gradually rises to the pre-determined air pressure level, then decompresses and the air pressure drops. | |||
| Once the top section decompresses, the cycle begins again. again. |
Normatec Pulse mode:
Starting with the distal zone and progressing up the proximal zone, one zone compresses and the pressure gradually rises to the pre-determined air pressure level, holds the air of previous two zone, the other zones do not hold, until the last zone finished, deflate the all last three zone then enter into next cycle. | Although the subject device provides six kinds of work mode, the Mode A is the same with predicate device (K160608), while the other work modes of subject device just have difference about the inflatable order of the different chambers. The treatment pressure range are the same under different work modes, so the difference of pressure range would not raise adversely impact on safety and effectiveness. |
| | setup pressure or for 40 seconds, hold air for 2 seconds,
then deflating, same way for chamber ⑤⑥ till
chamber ⑦⑧, pause for 3 second. Then repeat.
D (Whole Squeeze Mode): chamber ①②③④⑤⑥⑦
⑧ inflating at the same time till setup pressure or for
90 seconds, then deflating in the same time for 3
seconds. Then repeat.
E (Combined B + C): sequential squeeze + double
wave
F (Combined A + C + D): normal + double wave +
whole squeeze.
Image: [leg_compression] | | |
| Safety feature | Button on display allows user to stop or pause therapy
session at any time | Button on display allows user to stop or
pause therapy session at any time | Same |
| Technology | Compressor and valve system which sequentially
inflates inflatable chambers | Compressor and valve system which
sequentially inflates inflatable chambers | Same |
Table 6A: Summary of Comparison
6
K210967: 510(K) Summary
7
K210967: 510(K) Summary
8
K210967: 510(K) Summary
9
Performance Characteristic
The pressure therapy system has been tested and met the requirements of the following standards:
IEC 60601-1-11: 2015 - Medical electrical equirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical 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 Standad: Electromagnetic Compatibility
ANSI AAMI ES60601-1:20:51(R)2012 and A1:2012, C1:2009(R)2012 - Medical electrical equipment - Pat 1: General requirements for basic safety and essential performance
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
Conclusion
Based on the indications for use, technological characteristical performance data, "Air Pressure Therapy System. VU-IPC06 (K210967)" is as safe, as effective, and performs as well as the legally marketed predicate devices, "NormaTec Pulse Pro (K160608)". Therefore, the subject device is substantially equivalent to the predicate device.