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.

AI/ML Overview

The provided text is a 510(k) summary for the "Air Pressure Therapy System: VU-IPC06". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a clinical study proving its own independent performance against acceptance criteria.

The submission explicitly states:

"Performance Testing - Clinical: NOT Applicable." (Page 4)
"Performance Testing - Animal: NOT Applicable." (Page 4)

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Instead, it relies on a comparison to a predicate device (NormaTec Pulse and NormaTec Pulse Pro, K160608) to establish substantial equivalence.

The table below summarizes what could be considered acceptance criteria based on standard compliance and a comparison of the subject device's performance to its predicate. However, it's crucial to understand these are not acceptance criteria from an independent performance study of the subject device but rather a demonstration of similarity to a cleared device.

Summary of Device Comparison (No Independent Performance Study Provided)

1. Table of Acceptance Criteria and Reported Device Performance

Since no independent performance study is reported for the subject device against acceptance criteria, the table below reflects a comparison to the predicate device, which is the basis for its 510(k) clearance. The "acceptance criteria" here implicitly refer to being "as safe and effective" as the predicate.

Feature/Characteristic	Predicate Device (K160608) Performance	Subject Device (K210967) Performance	Differences/Conclusion
Indications for Use	Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.	Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.	Same
Pressure Range	30-110mmHg	30-110mmHg	Same
Regulation Number	21 CFR 890.5650	21 CFR 890.5650	Same
Classification Name	Massager, Powered Inflatable Tube	Massager, Powered Inflatable Tube	Same
Regulation Class	Class II	Class II	Same
Product Code	IRP	IRP	Same
Rx or OTC	OTC	OTC	Same
Mode of Compression	Sequential Gradient, Peristaltic and Pulsing	Sequential	Same (Subject device's "Mode A" is same as predicate; other modes are variations in inflation order)
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
Treatment Time	User controlled 10 minutes to 175 minutes or continuous	1-99min	Similar; subject device's shorter maximum time is deemed not to raise adverse impact on safety/effectiveness.
Standards Compliance	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-5, ISO 10993-10	Similar (Subject device additionally lists ISO 10993-5, ISO 10993-10 for biocompatibility, which are standard for medical devices in direct contact with skin.)

Note: The differences identified (e.g., treatment time, specific modes of compression) are evaluated to ensure they do not raise adversely impact or safety and effectiveness compared to the predicate, rather than meeting specific performance thresholds for the device itself.

2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable, as no clinical performance study on a test set (human subjects or patient data) was conducted or reported for the substantially equivalent device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable, as no clinical performance study was conducted.

4. Adjudication Method for the Test Set:
Not applicable, as no clinical performance study was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device (air pressure therapy system), not an algorithm or software-only device.

7. The type of ground truth used:
Not applicable, as no clinical performance study was conducted. The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate device based on its prior clearance and generally accepted standards for this type of device.

8. The sample size for the training set:
Not applicable, as no algorithm training or performance study was conducted or reported.

9. How the ground truth for the training set was established:
Not applicable, as no algorithm training or performance study was conducted or reported.

Summary

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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.

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

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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

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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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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
Email	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
Email	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

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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

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-IPC06	NormaTec Pulse and NormaTec PulsePro	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 forhome to temporarily relieve minor muscle aches and/orpains, and to temporarily increase circulation to thetreated areas.	The NormaTec Pulse and Pulse Pro is anair pressure massager intended totemporarily relieve minor muscle achesand/or pains, and to temporarily increasecirculation 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 canbe set up to turn off in a range of 10mins to continuous / User controlled 10minutes to 175 minutes or continuous-total time over 4 segments.	SimilarThe treatment time ofsubject device is smallerthan predicate device(K160608), so thedifference of treatment
			time would not raiseadversely impact orsafety and effectiveness.
Standard	ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012IEC 60601-1-2IEC 60601-1-11ISO 10993-5ISO 10993-10	ES 60601-1,IEC 60601-1-2,IEC 60601-1-11	Similar
Mode of compression	Sequential	Sequential Gradient, Peristaltic andPulsing	Same
Power source	110-120V, 50/60Hz	12 VDC via an IEC 60601-1 compliantpower 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 appearanceof sleeves (leg part)	Image: a blue leg sleeveLeg sleeve:M: 91*65cm	Image: a black leg sleeveShort: 14" x 43"Standard: 14" x 48"	Similar
	L: 10074cmXL: 11070cm (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 andprogressing 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 tillchamber ⑦⑧, pause for 3 second. Then repeat.D (Whole Squeeze Mode): chamber ①②③④⑤⑥⑦⑧ inflating at the same time till setup pressure or for90 seconds, then deflating in the same time for 3seconds. Then repeat.E (Combined B + C): sequential squeeze + doublewaveF (Combined A + C + D): normal + double wave +whole squeeze.Image: [leg_compression]
Safety feature	Button on display allows user to stop or pause therapysession at any time	Button on display allows user to stop orpause therapy session at any time	Same
Technology	Compressor and valve system which sequentiallyinflates inflatable chambers	Compressor and valve system whichsequentially inflates inflatable chambers	Same

Table 6A: Summary of Comparison

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K210967: 510(K) Summary

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K210967: 510(K) Summary

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K210967: 510(K) Summary

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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.

Regulation Number and Section

§ 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).