Air compression leg massager, model:FE-7204B, is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated foot/calf and thigh in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using air-inflatable boots.

Device Description

The Air Compression Leg Massager (model: FE-7204B) is a powered inflatable tube massager intended to be an over-the counter portable tube massage system which simulates kneading and stroking of foot, calf, and thigh by the use of inflatable air compression boots. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device is to be used by persons who are in good health. The device is non-sterile and utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and two solenoid valves. The pump, solenoids and other components are protectively housed within the acrylonitrile butadiene styrene (ABS) plastic enclosure of the control unit. On the bottom of the control unit, there are 3 ports which include the following: . Two ports (L and R) for connecting the air compression boots (left (L) and right (R)) by the air hose which is permanently attached to the air compression boots . One port for connecting the alternating current (AC) adaptor which will convert line power into direct current (DC) power. The subject device is comprised of the following components: - Control Unit - AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A) for converting line power to DC power - Connector Air Hose (connects Control Unit to the inflatable air compression boots) - Air compression boots which consist of three (3) air chambers/bladders encased inside a soft medical material.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Air Compression Leg Massager (model: FE-7204B). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for efficacy. The "acceptance criteria" discussed here are related to regulatory compliance and safety/performance standards, not clinical performance metrics.

Here is an analysis based on the provided text, structured according to your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" in terms of clinical performance (e.g., a specific reduction in muscle aches or circulation increase percentage). Instead, acceptance is implied by adherence to recognized non-clinical standards and the demonstration of substantial equivalence to a predicate device. The "reported device performance" is largely described through its characteristics and comparison to the predicate.

Acceptance Criterion (Implicit for Regulatory Clearance)	Reported Device Performance (Non-Clinical Compliance)
Electrical Safety: Compliance with general requirements for safety.	Met ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
Electromagnetic Compatibility (EMC): Compliance with EMC requirements.	Met IEC 60601-1-2:2014.
Home Healthcare Environment Safety: Compliance for devices used in home healthcare.	Met IEC 60601-1-11:2015.
Biocompatibility (Cytotoxicity): No in vitro cytotoxicity.	Met ISO 10993-5:2009.
Biocompatibility (Irritation & Skin Sensitization): No irritation or skin sensitization.	Met ISO 10993-10:2010.
Software Verification & Validation: Software functions correctly and safely.	Met "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices."
Substantial Equivalence: Device is as safe and effective as a legally marketed predicate device.	Demonstrated by comparing technological characteristics and intended use to K182668, noting differences do not raise new questions of safety or effectiveness, supported by non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Summary for clinical test: Clinical performance is not deemed necessary." Therefore, there was no clinical test set with human subjects used to prove the device meets performance criteria. The "tests" mentioned are non-clinical, conducted on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical study requiring expert-established ground truth was performed for this 510(k) submission. The ground truth for the non-clinical tests (e.g., electrical safety, EMC) is derived from the objective standards themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study requiring adjudication of human subject data was performed.

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 an air compression massager, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests conducted, the "ground truth" is defined by the specific requirements and methodologies outlined in the referenced international standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). The device's performance against these standards constitutes the "truth" for regulatory compliance in this context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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March 3, 2022

Xiamen Healthpal Electronic Co.,Ltd Henry Zhang Manager No.170 Siming Park Tongan District, Xiamen City, Fujian Province, China Xiamen, Fujian 361100 China

Re: K211850

Trade/Device Name: Air Compression Leg Massager (model: FE-7204B) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: January 26, 2022 Received: February 2, 2022

Dear Henry Zhang:

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

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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 medical devices and radiation-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).

Sincerely,

for 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

510(k) Number (if known) K211850

Device Name

Air Compression Leg Massager (model: FE-7204B)

Indications for Use (Describe)

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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510(k) Summary

The assigned 510(k) number is: K211850 Prepared date: January 25, 2022

Submitter Identification:

Name: Xiamen Healthpal Electronic Co., Ltd. Address: No.170 Siming Park Tongan District, Xiamen City, Fujian Province. China Xiamen, Fujian 361100

Contact Person: Henry Zhang Phone: +86-571-81957767 Fax: +86-571-81957750 Email: zyhenry@163.com

Name of the Device:

Trade Name: Air Compression Leg Massager (model: FE-7204B) Classification Name: Powered Inflatable tube massager

Classification Information:

Regulation Number: 21 CFR 890.5650 Product Code: IRP Device Class: II Review Panel: Physical Medicine

Predicate Device Information:

Sponsor Name: Rapid Reboot Recovery Products. LLC 1396 W 200 S Bldg 2A, Lindon, UT 84042, USA Trade/Device Name: Rapid Reboot Compression Therapy System 510(k) Number: K182668

Device Description:

The device is non-sterile and utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and two solenoid valves. The pump, solenoids and other components are protectively housed within the acrylonitrile butadiene styrene (ABS) plastic enclosure of the control unit. On the bottom of the control unit, there are 3 ports which include the following:

. Two ports (L and R) for connecting the air compression boots (left (L) and right (R)) by the air hose which is permanently attached to the air compression boots
. One port for connecting the alternating current (AC) adaptor which will convert line power into direct current (DC) power.

The subject device is comprised of the following components:

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Control Unit
· AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A) for
- converting line power to DC power
· Connector Air Hose (connects Control Unit to the inflatable air compression boots)
Air compression boots which consist of three (3) air chambers/bladders encased inside a soft medical material.

Characteristics of Air Compression Leg Massager (Model: FE-7204B)

No	Characteristics
1	Powered by AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A)
2	Power consumption: 24 W
3	Size of the control unit (±0.5cm) (Length 20cm ×Height 5.0cm× Width5.5cm)
4	Massage intensity (weak-medium-strong)Foot: Weak: 23±2kPa Medium: 27±2kPa Strong: 31 ±2kPaCalf: Weak: 23±2kPa Medium: 27±2kPa Strong: 31 ±2kPaThigh: Weak: 23±2kPa Medium: 27±2kPa Strong: 31 ±2kPa
5	LCD backlight
6	LCD size (viewing area ±0.2cm)(2.0cm×3.5cm)
7	Size of Inflatable boots(Size: ±2cm)1) Size: 71.5cm ×25cm2) The boots are suitable for the users with the following:● Foot width : about 12 cm to about 16 cm.● Calf diameter: about 16.5 cm to about 24cm.● Thigh diameter: about 19 cm to about 33cm.
8	Picture of the bootsImage: Picture of the boots
9	A pair of boots are exclusively for single person use only.Boots material: Nylon with a polyurethane laminate, and Velcro made of nylonAir bladder/chamber: TPU (Thermoplastic polyurethanes)Plastic components:
2.	Lens: PMMA (polymethyl methacrylate)
3.	Air hose: PVC (polyvinyl chloride)

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Intended Use/Indication for use :

Air compression leg massager, model:FE-7204B, is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated foot/calf and thigh in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using air-inflatable boots.

Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following standards in connection with medical device electrical safety, electromagnetic compatibility, biocompatibility, and software verification and validation:

(a) ANSI/AAMI ES60601-1 Medical Electrical Equipment-Part1: General Requirements for safety, 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.

(b) IEC 60601-1-2, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests, 2014.

(c) IEC 60601-1-11, Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral standard: Requirements formedical electrical equipment and medical electrical systems used in the home healthcare environment, Edition 2.0 2015-01.

(d) ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.

(e) ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization.

(f) Guidance for the content of Premarket Submissions for Software Contained in Medical Devices.

Technological comparison with the predicate device:

Compared with the predicate device, the subject device is similar in design principle, intended use, indications for use, functions, and material, and have been tested to applicable standards. The differences between subject device and predicate device do not raise new questions of safety or effectiveness. See comparison below:

Elements ofcomparison	Subject device K211850 )	Predicate Device (K182668)	Conclusion
Manufacturer	Xiamen Healthpal Electronic Co., Ltd.	Rapid Reboot Recovery Products,LLC	--
Product model	FE-7204B	Rapid Reboot Compression TherapySystem	--
Regulation name	Powered Inflatable Tube Massager	Powered Inflatable Tube Massager	Identical

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Xiamen Healthpal Electronic Co.,Ltd.

Regulation class	II	II	Identical
Regulationnumber	21 CFR 890.5650	21 CFR 890.5650	Identical
OTC or Rx	OTC	OTC	Identical
Indications foruse	Air compression leg massager,model:FE-7204B, is intended for thetemporary relief of minor muscle achesand pains and for the temporaryincrease in circulation to the treatedfoot/calf and thigh in people who are ingood health. The air compression legstroking of tissues by using air-inflatable boots.	The Rapid Reboot CompressionTherapy System is intended for thetemporary relief of minor muscleaches and pains and for thetemporary increase in circulation tothe treated areas in people who arein good health. The Rapid RebootCompression Therapy Systemsimulates kneading and stroking oftissues by using an inflatablegarment.	Similar Note1
Intended useenvironment	Clinics, hospital, athlete training, andhome environments	Clinics, hospital, athlete training,and home environments	Identical
Treatment area	Leg (including Foot, calf and thigh)	Leg (including Foot, calf andthigh), Hip, arm	Similar Note2
Therapy time	20 minutes	User determines therapy time.Choose from 10, 20, or 30 minutesession time, with option to addadditional 10 minutes to anytherapy time.	DifferentNote 3
	The subject device consists of an airpump, two solenoid valves, and aircompression boots working togetheras one unit. By inflating and deflatingthe air chambers through the control of	2 modes: "A" mode inflates anddeflates chambers from bottom up(distal to proximal chambers), oneat a time. "B" mode also inflateschambers from bottom up, but
Modes (visualdescription)	working and/or not working air pumpand solenoid valves at a regular paceand different timing, the componentssimulate kneading and stroking of thefoot, calf and thigh. There are 3 modesfor the subject device.Mode 1: PressingImage: [pressing mode]Massage the foot, calf and thigh,Mode 2: kneadingImage: [kneading mode]Massage the calf-thighMode 3: ShiatsuImage: [shiatsu mode]Massage the foot	maintains pressure in lowerchambers as works its way to top.Then all chambers release pressure atsame time once all chambers havesequentially inflated.Mode A:Image: [mode a]Mode B:Image: [mode b]	DifferentNote 4
Output pressurerange	0-33 kPa	0-200 mmHg	DifferentNote 5
Power source	AC100-240V,50/60Hz	110 V, 60Hz	DifferentNote 6
Powerconsumption	24W	30W	DifferentNote 7
Photo/size of thecontrol unit	Image: [control unit 1](Length 20cm ×Height5.0cm× Width5.5cm )	Image: [control unit 2]10" x 6.5" x 5" (in)	DifferentNote 8
Weight	About 1.25kg	5.8 pounds	DifferentNote 9
HousingMaterials	Molded ABS enclosure	Molded ABS enclosure	Identical
Photo and size ofthe boots for leg(foot, calf andthigh)	Size: 71.5cm ×25cmThe feet, calves and thighs which aresuitable for the users with thefollowing measurements:● Foot width : about 12 cm to about16 cm.● Calf diameter: about 16.5 cm toabout 24 cm.● Thigh diameter: about 19 cm toabout 33 cmA pair of boots is for single personuse only.	X-Short: 14" x 41"Short: 14" x 43"Medium: 14" x 45"Long: 14" x 48"X-Long: 14" x 52"	DifferentNote 10
Safety Features	Button on display allows user to stop orpause therapy session at any time.	Button on display allows user to stopor pause therapy session at any time.	Identical
Number ofchambers	3-chamber	4-chamber	DifferentNote 11
Sleeve materials	Nylon with a Polyurethane laminate	Nylon with a Polyurethane laminate	Identical
Mode ofcompression	Sequential	Sequential	Identical
Patient contact	Non-conductive appliances	Non-conductive appliances	Identical
Software/firmware/microprocess orcontrol	Microprocessor	Microprocessor	Identical
	FDA-recognized standards
Electrical safety,EMC, Bio-compatibility	ANSI/AAMI ES60601-1IEC 60601-1-2IEC60601-1-11ISO 10993-5ISO 10993-10	IEC 60601-1IEC60601-1-2ISO 10993-5ISO 10993-10	SimilarNote 12

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Xiamen Healthpal Electronic Co.,Ltd.

Note 1 and Note 2:

The predicate device covers the leg (consisting of foot, calf, knee, upper leg), hip and arm. The subject device covers similar treatment areas including the foot, calf and thigh.

Note 3 and Note 4:

Although the subject device is different than the predicate device in therapy time and massage mode, the subject device has been tested per ANSI/AAMI ES60601-1,IEC

60601-1-2, IEC 60601-1-11, and the software of the subject device has been validated

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per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, so the difference of therapy and massage modes would not adversely impact safety and effectiveness.

Note 5, Note 6 and Note 7:

Although the subject device is different than the predicate device in output pressure range and power source and power consumption, the subject device has been tested per ANSI/AAMI ES60601-1,IEC 60601-1-2 and IEC 60601-1-11, so the difference would not adversely impact safety and effectiveness.

Note 8 and Note 9:

Although the subject device is different than the predicate device in the weight and the size of control unit, it is believed that the difference in design would not adversely impact safety and effectiveness.

Note 10:

Although the subject device is different than the predicate device in boot size, it is believed that the difference in design would not adversely impact safety and effectiveness.

Note 11:

Although the subject device is different than the predicate device as it pertains to the air chamber, the subject device has been tested per ANSI/AAMI ES60601-1, IEC 60601-1-2 and IEC 60601-1-11, so the difference would not adversely impact safety and effectiveness.

Note 12:

The subject device was tested per the standards noted for the predicate device (ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 10993-5, and ISO 10993-10), in addition to IEC 60601-1-11.

Summary for clinical test:

Clinical performance is not deemed necessary.

Conclusions:

The Air compression leg massager (model:FE-7204B) has the same indication for use and similar technological characteristics when compared to the predicate device, the Rapid Reboot Compression Therapy System (K182668).Moreover, verification and validation tests contained in this submission demonstrate that the differences between the subject and the predicate devices does not:

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(1) affect the intended use or (2) alter the safety of the device, and the subject device a is considered substantial 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).