Compression Therapy Device (LGT-2202DVT)
Device Facts
| Record ID | K250242 |
|---|---|
| Device Name | Compression Therapy Device (LGT-2202DVT) |
| Applicant | Guangzhou Longest Medical Technology Co., Ltd. |
| Product Code | JOW · Cardiovascular |
| Decision Date | Apr 24, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
1. Leg Compression with sleeve is indicated for: - Deep vein thrombosis and pulmonary embolism prophylaxis. 2. Foot Compression with sleeve is indicated for: - Circulation enhancement - Deep vein thrombosis prophylaxis - Edema - Acute - Edema - Chronic - Extremity pain incident to trauma or surgery - Leg Ulcers - Venous stasis / venous insufficiency The compression Therapy Device is designed to be used in patients over 22 years old.
Device Story
Compression Therapy Device (LGT-2202DVT) is an intermittent pneumatic compression system for clinical/hospital use. System consists of controller, inflatable sleeves, and hoses. Controller inflates/deflates sleeves sequentially to apply external pressure to limbs; promotes blood/lymph circulation; prevents thrombus; reduces limb edema. Operated by healthcare professionals. Output is mechanical compression of limbs. Benefits include improved microcirculation and prophylaxis against DVT/pulmonary embolism. Device is non-invasive and external.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), and biocompatibility (ISO 10993-5, -10, -23).
Technological Characteristics
Intermittent pneumatic controller; AC 100-240V power; 11.1V 3500mAh lithium battery. Sequential compression modes (M1-M4). Pressure settings: 30/40/45 mmHg (calf/thigh), 130 mmHg (foot). Biocompatible materials per ISO 10993. IPX0 ingress protection. Class I, Type B applied part.
Indications for Use
Indicated for patients >22 years old requiring DVT/pulmonary embolism prophylaxis, circulation enhancement, edema management (acute/chronic), treatment of extremity pain from trauma/surgery, leg ulcers, or venous stasis/insufficiency.
Regulatory Classification
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.
Predicate Devices
- Kendall SCD 700 Sequential Compression Controller (K120944)
Reference Devices
- VESOFLOW R PLUS DVT Compression Device (K141064)
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
April 24, 2026
Guangzhou Longest Medical Technology Co., Ltd.
% Jett Lee
Regulation Manager
Guangzhou Keada Biological Tech Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Guangzhou, 510020
China
Re: K250242
Trade/Device Name: Compression Therapy Device (LGT-2202DVT)
Regulation Number: 21 CFR 870.5800
Regulation Name: Compressible Limb Sleeve
Regulatory Class: Class II
Product Code: JOW
Dated: April 3, 2026
Received: April 3, 2026
Dear Jett 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 (the 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 available 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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K250242 - Jett Lee
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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
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K250242 - Jett Lee
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
# Meaghan Erlewein -S
For Nicole Gillette
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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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250242 | |
| Device Name Compression Therapy Device (LGT-2202DVT) | |
| Indications for Use (Describe) | |
| 1. Leg Compression with sleeve is indicated for: - Deep Vein Thrombosis and pulmonary embolism prophylaxis 2. Foot Compression with sleeve is indicated for: - Circulation enhancement - Deep Vein Thrombosis prophylaxis - Edema - Acute - Edema - Chronic - Extremity pain incident to trauma or surgery - Leg Ulcers - Venous stasis / venous insufficiency The Compression Therapy Device is designed to be used in patients over 22 years old. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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K250242
# 510 (K) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements according to 21CFR 870.5800 and there were no prior submissions for the subject device.
## 1. Submitter Information
Sponsor: Guangzhou Longest Medical Technology Co., Ltd.
Address: 301 of Building 1, No.96, Chuangqiang Road, Ningxi Street, Zengcheng District, Guangzhou, Guangdong Province, 511399, P.R. China.
Contact person: Xiaobing Luo
Title: Deputy general manager
Phone: +86) 20 6635 3999
Email: gzlongest@longest.cn
## 2. Subject Device Information
Type of 510(k) submission: Traditional
Classification: Compressible Limb Sleeve,
Trade Name: Compression Therapy Device
Model: LGT-2202DVT
Review Panel: Cardiovascular
Product Code: JOW
Regulation Number: 21 CFR 870.5800
Regulation Class: Class II
## 3. Predicate Device Information
Trade name: Kendall SCD 700 Sequential Compression Controller
Regulation number: 21 CFR 870.5800
Regulatory Class: Class II
Product Code: JOW
Premarket Notification: K120944
Manufacturer: COVIDIEN LLC
## 4. Device Description
The LGT-2202DVT is a compression therapy device comprised of an intermittent pneumatic controller, sleeves and connectable hoses. 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, it can prevent thrombus and reduce limb drops, and this kind of disease is related to blood and lymph circulation directly or indirectly.
Clinic purpose: Therapeutic and Rehabilitation
Use environments: Clinic and hospital
## 5. Intended use/ Indication for use
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Compression Therapy Device LGT-2202DVT is intended for is as follows:
5.1 Leg Compression with sleeve is indicated for:
- Deep vein thrombosis and pulmonary embolism prophylaxis.
5.2 Foot Compression with sleeve is indicated for:
- Circulation enhancement
- Deep vein thrombosis prophylaxis
- Edema - Acute
- Edema - Chronic
- Extremity pain incident to trauma or surgery
- Leg Ulcers
- Venous stasis / venous insufficiency
The compression Therapy Device is designed to be used in patients over 22 years old.
6. Test Summary
6.1 Performance test
6.1.1 Service life evaluation report
Considering the life of the product host and the service life of the main components, accessories, after the evaluation and validation of the life of the main components, it can be concluded that the service life of the intermittent pneumatic pressure system host up to 10 years, single patient use sleeve for 5000 times, connection hose for 1 year, the life of the main components up to 5 years
6.1.2 Performance test after reliability test was executed.
6.2 Electrical safety and electromagnetic compatibility (EMC)
- IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
- IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability.
6.3 Software Verification and Validation Testing
There is no wireless connection, Bluetooth, internet connection in the device, and Power socket is only for battery charging connection.
6.4 Animal Study
Animal testing was not required for this submission.
6.5 Clinical Testing
Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
6.6 Biocompatibility Testing:
- ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-5: 2009, Biological evaluation of medical device - Part 5: Test for in vitro Cytotoxicity.
- ISO 10993-23:2021, Biological evaluation of medical device- Part 23: Tests for irritation.
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7. Comparison to Predicate Device
The technological characteristics, features, specifications, materials, and intended use of compression therapy device are substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
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| Device Feature | Subject Device | Predicate Device (K120944) | Predicate Device (K141064) | Comments |
| --- | --- | --- | --- | --- |
| Trade name | Compression Therapy Device LGT-2202DVT | Kendall SCD 700 Sequential Compression Controller | VESOFLOW R PLUS DVT Compression Device (Model: SQS) | N/A |
| 510 (K) number | K250242 | K120944 | K141064 | N/A |
| Manufacturer | Guangzhou Longest Medical Technology Co., Ltd. | COVIDIEN LLC | Caremed Supply Inc. | N/A |
| Environment of use | Clinic and hospital | Hospital or home use | Clinic and hospital | Identical |
| Rx or OTC | Rx | Rx | Rx | Identical |
| Product code | JOW | JOW | JOW | Identical |
| Regulation number | 21CFR 870.5800 | 21CFR 870.5800 | 21CFR 870.5800 | Identical |
| Class | Class II | Class II | Class II | Identical |
| Indications for use | 1. Leg Compression with sleeve is indicated for:
• Deep vein thrombosis and pulmonary embolism prophylaxis.
2. Foot Compression with sleeve is indicated for:
• Circulation enhancement
• Deep vein thrombosis prophylaxis
• Edema - Acute
• Edema - Chronic
• Extremity pain incident to trauma or surgery
• Leg Ulcers | 1. The use of the Kendall SCD 700 Series Compression System with Leg Sleeves is indicated for:
• Deep vein thrombosis and pulmonary embolism prophylaxis.
2. The use of the Kendall SCD 700 Series Compression System with Foot Cuffs is indicated for:
• Circulation enhancement.
• Deep vein thrombosis prophylaxis.
• Edema - Acute.
• Edema - Chronic. | The Caremed Supply Inc. VESOFLOW PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis. | Identical |
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| | • Venous stasis / venous insufficiency | • Extremity pain incident to trauma or surgery.
• Leg Ulcers.
• Venous stasis / venous insufficiency. | | |
| --- | --- | --- | --- | --- |
| Application | Non-invasive, external | Non-invasive, external | Non-invasive, external | Identical |
| Product Dimension (WxLxH) | 145x166x188 mm | 196x173x185 mm (free standing)
196x173x114 mm (when placed on a foot board) | 7.54"x 5.12"x7.95" | Different but does not raise any new issue of substantial equivalence |
| Weight | 1.5 Kg | 2.3 Kg | 2.8kg | |
| Control panel | Yes | Yes | Yes | Identical |
| Set pressure | Calf/Thigh: 45, 40 and 30 mmHg
Foot Cuffs: 130 mmHg | Leg Sleeves: 45 mmHg
Foot Cuffs: 130 mmHg | Calf/Thigh : 45, 40 and 30mmHg
Foot: 130mmHg | Different but same as reference device
K141064 Calf/thigh: 45, 40 and 30 mmHg;
Foot: 130 mmHg. |
| Timer | Continuous | Continuous | Not published | Identical |
| Sleeve Type | DVT sleeves | DVT sleeves | Not published | Identical |
| Compression Mode | 4 modes (M1-M4) | Leg Sleeves: Sequential, Gradient, Circumferential; Foot Cuffs: Uniform | Sequential | Different but does not raise any new issue of substantial equivalence |
| Power source | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | AC 100-240V, 50/60Hz | Identical |
| Battery | Battery: 11.1V, 3500mAh, | Battery : 10.8 V, 2200mAh, | Not published | Different but does not |
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| | lithium battery Battery hours:9 h | Lithium Ion pack
Run Time: 6-8 hours
Charge Time: 4 hours (charging only) | | raise any new issue of substantial equivalence |
| --- | --- | --- | --- | --- |
| Mode of Operation | Continuous | Continuous | Not published | Identical |
| System of Protection | Class I, Type B Applied Part | Class I, Type BF | Not published | Different but does not raise any new issue of substantial equivalence |
| Ingress of water Protection | IPX0 | IP23 (IEC 529) | Not published | Different but does not raise any new issue of substantial equivalence |
| Anatomic location | Calf, thigh, foot | Leg (calf and thigh), foot | Leg (calf and thigh), foot | Identical |
| Electrical Safety | Evaluated according to IEC 60601-1 | Evaluated according to IEC 60601-1 | Evaluated according to IEC 60601-1 | Identical |
| EMC | Evaluated according to IEC 60601-1-2 | Evaluated according to IEC 60601-1-2 | Evaluated according to IEC 60601-1-2 | Identical |
| Environmental Conditions of Operation | Temperature: 5 to 40 °C
Rel. humidity: ≤80%
Atmosphere Pressure: 62 to 106 kPa | Temperature: 10 to 40 °C
Rel. humidity:85 % Maximum, non-condensing
Atmosphere Pressure: 700-1060 hPa | Rel. humidity: 30-75%
Temperature:15- 35°C | Different but does not raise any new issue of substantial equivalence |
| Environmental Conditions of Transport and Storage | Temperature: -20 to 55 °C
Rel. humidity: ≤93 %
Atmosphere Pressure: 62 to 106 kPa | Temperature: -20 to 55 °C | Not published | Different but does not raise any new issue of substantial equivalence |
Conclusion: The Compression Therapy Device has the same intended use, technology, design and performance specifications are either identical or substantially
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equivalent to existing legally marketed predicate devices. The differences between the Compression Therapy Device do not alter suitability of the proposed device for its intended use.
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8. Summary Prepared Date
30Mar2026
