(323 days)
Not Found
No
The device description and performance studies focus on mechanical compression and standard electrical/software safety testing, with no mention of AI or ML algorithms.
Yes
The device is described as being "intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers," and for "prophylaxis of deep vein thrombosis (DVT)," which are all therapeutic purposes.
No
The device description and intended use clearly state that it is a compression therapy device used for treatment and prophylaxis of various conditions, not for diagnosing them. It promotes blood/lymph circulation and prevents thrombus.
No
The device description explicitly states it consists of physical components like leg cuffs, air hoses, and a handheld controller with a built-in vacuum pump. It is a hardware-based compression therapy device with some software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Venen-trainer is a compression therapy device that applies external pressure to the limbs. It works by physically manipulating the body's circulation through inflation and deflation of air cuffs.
- Intended Use: The intended uses listed (treatment of lymphedema, edema, venous insufficiency, DVT prophylaxis, etc.) are all related to physical therapy and circulatory support, not diagnostic testing of biological samples.
The device description and intended use clearly indicate that it is a therapeutic device that interacts directly with the patient's body, not a device used to analyze samples in a laboratory setting.
N/A
Intended Use / Indications for Use
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.
Product codes
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot / Calves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or healthcare setting.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
1
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)
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.
| 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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3
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
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
4
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
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.
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 of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | SHENZHEN PANGO | ||
| ELECTRONIC 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 | -- | ||
| Classification | |||
| Name | Sleeve, Limb, Compressible | Sleeve, Limb, Compressible | Same |
| Classification | Class II Device, JOW (21 | ||
| CFR870.5800) | Class II Device, JOW (21 | ||
| CFR870.5800) | Same | ||
| Prescription or | |||
| OTC | Prescription | Prescription | Same |
| Intended use | 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. | The Bio Compression Systems' | ||
| Sequential Circulators are | |||
| sequential, pneumatic | |||
| compression devices intended for | |||
| either primary or adjunctive | |||
| treatment of lymphedema, | |||
| peripheral edema, lipedema, | |||
| venous insufficiency, and venous | |||
| stasis ulcers. Sequential | |||
| Circulators are also intended for | |||
| the prophylaxis of deep vein | |||
| thrombosis (DVT). | |||
| Intended for use in a home or | |||
| healthcare setting. | Same | ||
| Anatomy | Foot / Calves | Limbs | Similar |
| Note 1 | |||
| Elements of | |||
| Comparison | 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: 3.3 | ||
| lbs. (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) | Similar | ||
| Note 2 | |||
| Dimension | For model FM150: | ||
| 169.775.937.3mm | |||
| For model SFM90: | |||
| 168.375.633.5mm | • 1000 series: 4.5" x 11.75" x | ||
| 7.75" (114mm x 298mm x | |||
| 197mm) | |||
| • 2000/4000 series: 4.5" x 12" x | |||
| 7.34" (114mm x 304mm x | |||
| 186mm) | Similar | ||
| Note 2 | |||
| Power | 100-240VAC 50/60Hz | ||
| 0.2A converted to DC 6V 500mA | |||
| or 6V DC AA batteries LR6 *4 | 120-240V, 50/60 Hz | Similar | |
| Note 2 | |||
| Treatment Time | For model FM150: 10 min, 20 min, | ||
| 30 min | |||
| For model SFM90: 30 min | Continuous or adjustable as | ||
| follows: | |||
| • 1000 series: 30-120 minutes | |||
| adjustable in 30-minute | |||
| increments | |||
| • 2000/4000 series: 10-120 | |||
| minutes in 5-minute | |||
| increments | Similar | ||
| Note 2 | |||
| Cycle Time | 60-120s | • 1000 series: 60-120 seconds | |
| in 30-second increments | |||
| • 2000/4000 series: 60-120 | |||
| seconds in 15-second | |||
| increments | Same | ||
| Interface | |||
| Pressure Range | 0-120mmHg | • 20-100 mmHg, adjustable in | |
| 5mmHg increments | |||
| • 10-120 mmHg, adjustable in | |||
| 1mmHg increments | |||
| • 0-120 mmHg, adjustable in | |||
| 1mmHg increments | Same | ||
| Mode of | |||
| Operation | Continuous | Continuous or adjustable | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Electrical Safety | IEC 60601-1 | ||
| IEC 60601-1-11 | IEC 60601-1 | ||
| IEC 60601-1-11 | Same | ||
| Biocompatibility | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-5 | ||
| ISO 10993-10 | Same |
5
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.
6
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.