Venen-trainer (Model: FM150, SFM90) is intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers. These devices are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Device Description

Venen-Trainer (model: FM150, SFM90) is a compression therapy device, consists of two leg cuffs with integrated inflation and deflation air cushions, two air hoses and a handheld controller. The working principle is the air inflating and deflating the sleeve sequentially to develop the circulating pressure on the human body. Squeezing the proximal and distal of the limbs to promote blood circulation lymphatic system and improve body microcirculation. Besides, prevent thrombus, reduce limbs drops and this kind disease which is related to blood and lymph circulation directly or indirectly. The two leg cuffs are each connected to one end of an air hose, and the other end of the two air hoses is connected to the controller. The air pressure controller has a built-in vacuum pump, and the air pressure intensity can be adjusted by the air pressure controller. Turn the knob clockwise to increase the intensity. The timer of FM150 can be switched between three timings of 10 minutes, 20 minutes, and the timer of SFM90 is only one timing of 30 minutes. The two leg cuffs are inflated alternately and will not be inflated simultaneously. In addition, there are hook and loop buckles on the foot cover to adjust the leg cuff to the shape of user's leg.

AI/ML Overview

This document is a 510(k) summary for the Venen-trainer (Model: FM150, SFM90), a compression therapy device. The submission aims to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document does not explicitly state acceptance criteria in the typical format of a table with specific metrics (e.g., sensitivity, specificity, accuracy) and corresponding thresholds for device performance. Instead, the "acceptance criteria" are implied by the demonstration of conformity to established medical device standards and functional equivalence to the predicate device. The device performance is primarily assessed through a series of lab bench tests.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Electrical Safety	Meets IEC 60601-1 and IEC 60601-1-11 standards
Electromagnetic Compatibility (EMC)	Meets IEC 60601-1-2 standard
Biocompatibility	Meets ISO 10993 (ISO 10993-5, ISO 10993-10) standards
Software Verification & Validation	Meets FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices" requirements
Functional Equivalence	Similar or same as predicate device (K210417) in terms of intended use, classification, operation, interface pressure range, cycle time, etc., with minor differences not affecting safety or effectiveness.
Physical Characteristics (Weight, Dimension, Power, Treatment Time)	Similar to predicate device, but meeting safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). Differences do not affect safety or effectiveness.

Study Details:

Sample sizes used for the test set and data provenance:
The document describes "lab bench testing" for electrical safety, EMC, biocompatibility, and software verification and validation. It does not mention a "test set" in the context of clinical or performance data involving human subjects or specific diagnostic outputs that would require a sample size. The testing appears to be hardware and software validation against technical standards. Therefore, information about sample size, country of origin, or retrospective/prospective nature is not applicable in this context.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This information is not applicable as the document does not describe a study involving expert-established ground truth on a test set (e.g., for diagnostic accuracy). The testing performed is related to compliance with engineering and safety standards.
Adjudication method for the test set:
This information is not applicable as there is no mention of a test set requiring adjudication in the context of diagnostic performance or clinical outcomes.
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:
This information is not applicable. The device described is a physical compression therapy device, not an AI-assisted diagnostic or therapeutic system involving human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is not an algorithm-only system. Its performance is assessed as a medical device against safety and performance standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the technical tests (electrical safety, EMC, biocompatibility, software V&V), the "ground truth" is adherence to the specified international and FDA standards (e.g., IEC 60601-1, ISO 10993) and the manufacturer's own design specifications. There is no biological or clinical "ground truth" established from patients or pathology in this submission.
The sample size for the training set:
This information is not applicable. The device is not an AI/ML device that requires a training set of data.
How the ground truth for the training set was established:
This information is not applicable for the same reason as point 7.

Summary

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November 10, 2021

Shenzhen Pango Electronic CO., LTD % Cassie Lee Manager Guangzhou Glomed Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510000 China

Re: K203746

Trade/Device Name: Venen-trainer (Model: FM150, SFM90) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 22, 2021 Received: September 29, 2021

Dear Cassie Lee:

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,

Nicole Gillette Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K203746

Device Name Venen-trainer (Model: FM150, SFM90)

Indications for Use (Describe)

Intended for use in a home or healthcare setting.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for K203746

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.109.

1. Submitter's Information

510(k) Owner's Name: SHENZHEN PANGO ELECTRONIC CO., LTD Establishment Registration Number: 3006792041 Address: No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang District Shenzhen, Guangdong, 518115, CHINA Tel: 86-13632731945 Fax: 86-755-33825989 Email: 125140668@qq.com

2. Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: requlatory@glomed-info.com

3. Subject Device Information

Type of 510(k): Traditional Classification Name: Sleeve, Limb, Compressible Trade Name: Venen-trainer Model Name: FM150, SFM90 Review Panel: Cardiovascular Product Code: JOW Regulation Number: 870.5800 Regulatory Class: 2

Predicate Device Information ব

Sponsor: Bio Compression Systems, Inc. Trade Name: Sequential Circulators Classification Name: Sleeve, Limb, Compressible 510(K) Number: K210417 Review Panel: Cardiovascular Product Code: JOW Requlation Number: 870.5800 Requlation Class: 2

5. Device Description

The two leg cuffs are each connected to one end of an air hose, and the other end of the two air hoses is connected to the controller. The air pressure controller has a built-in vacuum pump, and the air pressure intensity can be adjusted by the air pressure controller. Turn the knob clockwise to increase the intensity. The timer of FM150 can be switched between three

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timings of 10 minutes, 20 minutes, and the timer of SFM90 is only one timing of 30 minutes.

The two leg cuffs are inflated alternately and will not be inflated simultaneously. In addition, there are hook and loop buckles on the foot cover to adjust the leg cuff to the shape of user's leg.

6. Intended Use / Indications for Use

7. Test Summary

Venen-trainer has been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1 and IEC 60601-1-11 standards �
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Biocompatibility test according to ISO 10993 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"

8. Comparison to predicate device and conclusion

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Verdict
Company	SHENZHEN PANGOELECTRONIC CO., LTD	Bio Compression Systems, Inc.	--
510 (k)	K203746	K210417	--
Trade Name	Venen-trainer	Sequential Circulators	--
Model	FM150, SFM90	SC-1004-DL, SC-1008-DL,SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL	--
ClassificationName	Sleeve, Limb, Compressible	Sleeve, Limb, Compressible	Same
Classification	Class II Device, JOW (21CFR870.5800)	Class II Device, JOW (21CFR870.5800)	Same
Prescription orOTC	Prescription	Prescription	Same
Intended use	Venen-trainer (Model: FM150,SFM90) is intended for eitherprimary or adjunctive treatment oflymphedema, peripheral edema,lipedema, venous insufficiency,and venous stasis ulcers. Thesedevices are also intended for theprophylaxis of deep veinthrombosis (DVT).Intended for use in a home orhealthcare setting.	The Bio Compression Systems'Sequential Circulators aresequential, pneumaticcompression devices intended foreither primary or adjunctivetreatment of lymphedema,peripheral edema, lipedema,venous insufficiency, and venousstasis ulcers. SequentialCirculators are also intended forthe prophylaxis of deep veinthrombosis (DVT).Intended for use in a home orhealthcare setting.	Same
Anatomy	Foot / Calves	Limbs	SimilarNote 1
Elements ofComparison	Subject Device	Predicate Device	Verdict
Weight	For model FM150: Approx. 1.6kg(including packaging)For model SFM90: Approx. 1.95kg(including packaging)	• SC-1004-DL, SC-2004-DL: 3.3lbs. (1.5 kg)• SC-1008-DL, SC-2008-DL:3.65 lbs. (1.66 kg)• SC-4004-DL: 3.5 lbs. (1.59 kg)• SC-4008-DL: 3.85lbs (1.75 kg)	SimilarNote 2
Dimension	For model FM150:169.775.937.3mmFor model SFM90:168.375.633.5mm	• 1000 series: 4.5" x 11.75" x7.75" (114mm x 298mm x197mm)• 2000/4000 series: 4.5" x 12" x7.34" (114mm x 304mm x186mm)	SimilarNote 2
Power	100-240VAC 50/60Hz0.2A converted to DC 6V 500mAor 6V DC AA batteries LR6 *4	120-240V, 50/60 Hz	SimilarNote 2
Treatment Time	For model FM150: 10 min, 20 min,30 minFor model SFM90: 30 min	Continuous or adjustable asfollows:• 1000 series: 30-120 minutesadjustable in 30-minuteincrements• 2000/4000 series: 10-120minutes in 5-minuteincrements	SimilarNote 2
Cycle Time	60-120s	• 1000 series: 60-120 secondsin 30-second increments• 2000/4000 series: 60-120seconds in 15-secondincrements	Same
InterfacePressure Range	0-120mmHg	• 20-100 mmHg, adjustable in5mmHg increments• 10-120 mmHg, adjustable in1mmHg increments• 0-120 mmHg, adjustable in1mmHg increments	Same
Mode ofOperation	Continuous	Continuous or adjustable	Same
EMC	IEC 60601-1-2	IEC 60601-1-2	Same
Electrical Safety	IEC 60601-1IEC 60601-1-11	IEC 60601-1IEC 60601-1-11	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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Comparison in Detail(s):

Note 1:

Although the "Anatomy" of subject device is little difference with predicate device, the legs of this anatomy is included in the limbs. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

Note 2:

Although the "Weight", "Dimensions", "Power" and "Treatment Time" of subject device is a little difference with predicate device, they all meet the requirements of safety and performance standard IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11. So, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

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Final Conclusion:

The subject device Venen-trainer (Model: FM150, SFM90) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device K210417.

9. Date of the summary prepared: November 10, 2021

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).