Air Pressure Foot Massager is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Device Description

Air Pressure Foot Massager has a pump. The pump is connected with the dedicated inflatable sleeve through the hose, one sleeve has 2 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.

The device is equipped with a hand controller. In operation, the user simply turns the power on via the power button. The intensity (pressure) can be adjusted by purpose to avoid any discomfort. The device is powered by an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery. The materials of sleeve use medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.

The Air Pressure Foot Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue by use of an inflatable sleeve. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

AI/ML Overview

The provided text is a 510(k) Summary for the "Air Pressure Foot Massager" (K212935). It details the device's characteristics, its intended use, and its comparison to a predicate device (K201935) to establish substantial equivalence.

However, this document does not contain the kind of information typically found in a study that describes acceptance criteria and proves a device meets them, especially from a clinical performance or AI algorithm perspective. This document focuses on demonstrating substantial equivalence to an existing predicate device based on non-clinical tests and comparisons of specifications.

Specifically, the document lacks:

A table of acceptance criteria for performance metrics where the device's performance is reported against those criteria. The tables provided are for general device characteristics and safety comparisons, not performance against specific clinical or diagnostic thresholds.
Details on sample size, data provenance, expert qualifications, or adjudication methods for a test set, as no clinical study or performance evaluation against ground truth is presented.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Details about a training set, how its ground truth was established, or its sample size.

The document explicitly states: "No clinical study is included in this submission." This indicates that the regulatory clearance was based on non-clinical data and comparison to a predicate device, rather than a clinical performance study.

Therefore,Based on the provided document, the requested information cannot be fully provided because the submission focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than a clinical study evaluating specific performance criteria against a ground truth.

Here's a breakdown of why each requested point cannot be fully addressed:

A table of acceptance criteria and the reported device performance:
- The document provides a "Substantially Equivalent (SE) Comparison" table (Table 1) and a "Safety Comparison" table (Table 3). These tables compare specifications and compliance with standards between the proposed device and the predicate device. They do not list specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific quantitative measures of effectiveness) and then report the device's performance against those criteria. Instead, they demonstrate that the proposed device's characteristics are similar to or comply with the same standards as the predicate device.
- For example, under "Pressure range," both devices are listed as "30-110mmHg," implying this is an accepted specification, but it's not a performance metric with an associated acceptance criterion.
Sample size used for the test set and the data provenance:
- Not applicable. No clinical test set or study involving human subjects or data is mentioned. The submission explicitly states: "No clinical study is included in this submission." Non-clinical tests were conducted to verify design specifications and compliance with safety standards (e.g., electrical safety, biocompatibility), but these do not involve a "test set" in the context of clinical or diagnostic performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical test set was used, there was no need for experts to establish ground truth in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was used.
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 Pressure Foot Massager" and does not involve AI or human "readers" in a diagnostic or interpretive capacity. It's a physical therapy/massage device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device does not incorporate an algorithm that operates in a standalone diagnostic or interpretive capacity.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this submission was compliance with established medical device standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and direct comparison of design specifications to a legally marketed predicate device.
The sample size for the training set:
- Not applicable. No training set for an AI algorithm or clinical model was used.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on non-clinical tests (safety, biocompatibility) and a thorough comparison of technical specifications to a predicate device, which is a common pathway for devices of this type. It was not a submission requiring clinical performance data or AI algorithm validation.

Summary

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February 19, 2022

Xiamen Simo Electronic Co., Ltd % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North RD. FangShan District Beijing, Beijing 102401 China

Re: K212935

Trade/Device Name: Air Pressure Foot Massager Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: December 24, 2021 Received: December 27, 2021

Dear Ray Wang:

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.

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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 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.

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) K212935

Device Name Air Pressure Foot Massager

Indications for Use (Describe)

Air Pressure Foot Massager 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 )
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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: K212935

1. Date of Preparation
  02/05/2022
Sponsor 2.

XIAMEN SIMO ELECTRONIC CO., LTD

Floor 3rd-5th, No.173 Siming Park, Tong'an Industrial Zone, Tong'an District, Xiamen City, Fujian Province, China, 361100 Contact Person: Wang Qinsheng Position: General Manager Tel: +86-13860109615 Fax: +86-592-5917070 Email: jeson@xmsimo.com

1. Submission Correspondent
  Contact Person:

Mr. Ray Wang Tel: +86-18910677558 Fax: +86-10-52214696 Email: information(@believe-med.com

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401

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4. Identification of Proposed Device

Trade Name: Air Pressure Foot Massager Common Name: Physical Medicine Model(s): SM-512F

Regulatory Information: Classification Name: Massager, Powered Inflatable Tube Classification: II; Product Code: IRP; Regulation Number: 21 CFR 890.5650; Review Panel: Physical Medicine.

Indication for Use:

Air Pressure Foot Massager is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

1. Device Description
  Air Pressure Foot Massager has a pump. The pump is connected with the dedicated inflatable sleeve through the hose, one sleeve has 2 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.

Identification of Predicate Device 6.
Predicate Device 510(k) Number: K201935 Product Name: Air Pressure Therapy System Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd.
1. Non-Clinical Test Conclusion

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Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

AAMI ES60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety And Essential Performance (IEC 60601-1);
IEC 60601-1-11: 2015, Medical electrical equipment - Part 1-11: General Requirements 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 equipment- Part 1-2: General requirements for basic A safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
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.
Clinical Test Conclusion 8.

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 9.

Table 1 General Comparison

ITEM	Proposed Device	Predicate Device (K201935)	Remark
Product Code	IRP	IRP	SAME
Regulation No.	21 CFR 890.5650	21 CFR 890.5650	SAME
Class	II	II	SAME
Indication For Use	Air Pressure Foot Massager is intended totemporarily relieve minor muscle achesand/or pains, and to temporarily increasecirculation to the treated areas.	Air Pressure Therapy System VU-IPC04Bis intended to temporarily relieve minormuscle aches and/or pains, and totemporarily increase circulation to thetreated areas.	SAME
Rx or OTC	OTC	OTC	SAME
Technology	Compressor and valve system whichsequentially inflates inflatable chambers.	Compressor and valve system whichsequentially inflates inflatable chambers.	SAME
ITEM	Proposed Device	Predicate Device (K201935)	Remark
Pressure range	30-110mmHg	30-110mmHg	SAME
Treatment time	0-30min, default as 15min	5-99mins	Analysis 1
Mode of compression	Sequential	Sequential	SAME
Power source	Voltage: DC5V 1A	AC 110-240V; 50Hz/60Hz	Analysis 2
	Lithium Battery: 3.7V, 2400mah (Batterymeet IEC 62133-2)	Battery meet IEC 62133-2
Power consumption	5W	35W	Analysis 2
Number of chambers	4pcs/Pair	6	Analysis 3
Size of the sleeves	340365360mm	M: 91x65cm, XL: 110x70cm(overlapping)XXL: 125x76cm(overlapping)	Analysis 4
Dimension	2115550mm	22014090mm	Analysis 4
Weight	$1.15\pm0.1$ kg	1.6Kg	Analysis 4
Work mode	Mode 1	Mode A:	Analysis 5
	The model is divided into two processes,	In this mode, only a single chamber is inflated at a
	the first process includes inflating,deflating and holding pressure. The	time. Starting from the chamber (1) and working up tothe chamber (6). Then the cycle repeats.
	inflating sequence of air chambers ofsleeves is:	Mode B:
	The chamber No.(1) Inflate and keeppressure three times, deflated, Then the	In this mode, the chamber (1) stays inflated. Itgradually adds a chamber until all six chambers arefilled with air. Then the cycle repeats.
	chamber No (2) inflate and keeppressure three times, deflated.	Mode C:
	In the second process, the air pump isalways opened, and the air is inflated	In this mode, chamber (1) inflates & deflates 4 times,then holds pressure; next chamber (2) inflates &deflates 4 times, chamber (1)(2) hold pressure;
	and deflated according to the followinginflating sequence:	chamber (3) inflates & deflates 4 times, chamber (2)(3)hold pressure, chamber (1) deflates; chamber (4)
	(1)(2)-(1)-(2)-(1)(2)-(1)-(2)-(1)(2)-(1)-(2)-(1)(2)-(1)-(2)-(2)-(1)	inflates & deflates 4 times, chamber (3)(4) holdpressure, chamber (2) deflates; working as this way upto chamber (6). Then the cycle repeats.
	The inflating time is different accordingto the intensity selected.	Note: Under this mode, for the FIRST CYCLE, itworks as mode B to warm up; from the 2nd cycle on,it works as PULSE Mode C.
	Mode 2	Mode D:
	In this model, at first ,the chamber No.(1) inflate and keep pressure four times,	In this mode, all chambers inflates together, anddeflates together. Then the cycle repeats
	then chamber No. (1)(2)are inflated anddeflated at the same time.
	Mode 3
	The chamber No. (1)(2) are inflated anddeflated at the same time, Then the cyclerepeats.

Item	Proposed Device	Predicate Device	Remark
EMC, Electrical and Laser Safety
Electrical Safety	Comply with IEC 60601-1,IEC60601-1-11	Comply with IEC 60601-1,IEC60601-1-11	SAME
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SAME
Battery Safety	Comply with IEC 62133-2	Comply with IEC 62133-2	SAME
Patient Contact Materials and Biocompatibility
Patient ContactMaterials	Terylene	Not Publicly Available	Analysis
Cytotoxicity	Comply with ISO 10993-5	Comply with ISO 10993-5	SAME
Sensitization	Comply with ISO 10993-10	Comply with ISO 10993-10	SAME
Irritation	Comply with ISO 10993-10	Comply with ISO 10993-10	SAME

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Analysis 1

Although the treatment time range of subject device is 0 to 30mins, which seems to be smaller than the predicate devices, the default value is 15min which is suitable for daily use. In the process of use, the user can start or stop at any time by the power button on the hand controller, so the difference of Treatment time would not raise adversely impact on safety and effectiveness.

Analysis 2

Although the subject device design and specification parameter between the predicate devices, they are both complied with IEC60601-1, so the minor differences of power source and Power consumption does not raise any new issue of the safety or effectiveness.

Analysis 3

Number of chambers is different, but the application site and treatment pressure range are the same. The minor difference of number of chambers does not raise any new issue of the safety or effectiveness.

Analysis 4

The proposed device is different in appearance, dimension and weight from the predicate device. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference will not affect the substantially equivalency.

Analysis 5

Although the work mode is different, while the difference of work modes just because the inflatable order of the different chambers. The treatment pressure range is the same under different work modes, so the difference of work mode would not raise adversely impact on safety and effectiveness.

Table 3 Safety Comparison

Analysis

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Although the materials in contact with human skin are different, they all meet the requirements of ISO 10993-5/10 and will not affect product safety.

10. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Air Pressure Foot Massager (SM-512F) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K201935.

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).