Compression Therapy Device (LGT-2210DS)

K250244 · Guangzhou Longest Medical Technology Co., Ltd. · IRP · Jul 25, 2025 · Physical Medicine

Device Facts

• Record ID: K250244
• Device Name: Compression Therapy Device (LGT-2210DS)
• Applicant: Guangzhou Longest Medical Technology Co., Ltd.
• Product Code: IRP · Physical Medicine
• Decision Date: Jul 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Compression Therapy Device (Model: LGT-2210DS) is intended for Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post-mastectomy lymphedema). Compression Therapy Device (Model: LGT-2210DS) is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in clinical and hospital. The compression Therapy Device (Model: LGT-2210DS) is designed to be used in patients over 22 years old.

Device Story

Compression Therapy Device (LGT-2210DS) is a powered inflatable tube massager for clinical/hospital use by medical professionals. Device consists of an intermittent pneumatic controller, connectable hoses, and 4- or 6-chamber sleeves. Principle of operation involves sequential inflation/deflation of sleeve chambers to apply circulating pressure to limbs, promoting blood and lymphatic circulation. Device features multiple compression modes (Sequential, Squeeze, Flush, Flow, Release, Wave) with adjustable pressure (7.5-187 mmHg) and treatment time (1-120 min). Clinicians operate the device to manage edema; output is mechanical compression. Benefits include improved microcirculation and edema reduction. No wireless/internet connectivity; client data export via USB flash drive requires password.

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

Powered inflatable tube massager; 4- or 6-chamber sleeves; microprocessor-controlled compressor and valve system. Dimensions: 385x348x185 mm; Weight: 10.0 kg. Power: AC 100-120V, 60 Hz. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for prophylaxis and treatment of edema, including chronic venous edema, lymphedema, and post-mastectomy lymphedema in patients over 22 years old. For use by medical specialists in clinical and hospital settings.

Regulatory Classification

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.

Predicate Devices

• Compressible Limb Therapy System MK300L (K112441)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 25, 2025

Guangzhou Longest Medical Technology Co., Ltd.
% Jett Li
Regulation Manager
Guangzhou KEADA Biological Tech Co., Ltd.
6F, No.1 TianTai road, Science City, LuoGang District
Guangzhou, 510010
China

Re: K250244
Trade/Device Name: Compression Therapy Device (LGT-2210DS)
Regulation Number: 21 CFR 890.5650
Regulation Name: Powered Inflatable Tube Massager
Regulatory Class: Class II
Product Code: IRP
Dated: June 27, 2025
Received: June 27, 2025

Dear Jett Li:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250244 - Jett Li
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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 systems (QS) regulation (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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K250244 - Jett Li
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

JULIA E. 2025.07.25
SLOCOM8-S 10:31:49 -04'00'

for Tushar Bansal, PhD
Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250244

Device Name
Compression Therapy Device (LGT-2210DS)

Indications for Use (Describe)
Compression Therapy Device (Model: LGT-2210DS) is intended for Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post-mastectomy lymphedema).
Compression Therapy Device (Model: LGT-2210DS) is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in clinical and hospital. The compression Therapy Device (Model: LGT-2210DS) 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)

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510(k) Summary
K250244

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements according to 21CFR 890.5650 and there were no prior submissions for the subject device.

1. Submitter Information
Sponsor: Guangzhou Longest Medical Technology Co., Ltd.
Address: 301&401 of Building 2&Building 3, No.96, Chuangqiang Road, Ningxi Street, Zengcheng District, Guangzhou, Guangdong Province.
Contact person: Xiaobing Luo
Title: Deputy general manager
Phone: [phone]
Email: [e-mail]

2. Subject Device Information
Type of 510(k) submission: Traditional
Classification: Powered inflatable tube massager
Trade Name: Compression Therapy Device
Model: LGT-2210DS
Review Panel: Physical Medicine
Product Code: IRP
Regulation Number: 21 CFR 890.5650
Regulation Class: Class II

3. Predicate Device Information
Trade name: Compressible Limb Therapy System MK300L
Regulation number: 21CFR 890.5650
Regulatory Class: Class II
Product Code: IRP
Premarket Notification: K112441
Manufacturer: DAESUNG MAREF CO.,LTD.

4. Device Description
The LGT-2210DS is a compression therapy device comprised of an intermittent pneumatic controller, sleeves with 6-chamber, 4-chamber combined 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.
Clinic purpose: Therapeutic and Rehabilitation
Suitable places: Clinic and hospital

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5. Intended use/ Indication for use

Compression Therapy Device LGT-2210DS is intended for use as follows:

Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post-mastectomy lymphedema).

Compression Therapy Device (Model: LGT-2210DS) is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in clinical and hospital.

The compression Therapy Device (Model: LGT-2210DS) 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 verification of the product host life, life evaluation and verification of the main components, can conclude that the service life of Compression Therapy Device host can reach 10 years, Reusable sleeve for 30000 times, the life of the main components up to 5 years.

6.1.2 Performance test after reliability test was executed.

6.1.3 Reliability bench 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. The client information can be exported by entered Password with USB flash drive. Testing related to Cybersecurity was performed.

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 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 devices — 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.

| Device Feature | Subject Device | Predicate Device (K112441) | Comment s |
| --- | --- | --- | --- |
| Trade name | Compression Therapy Device | Compressible Limb Therapy System MK300L | N/A |
| 510 (K) number | K250244 | K112441 | N/A |
| Manufacturer | Guangzhou Longest Medical Technology Co., Ltd. | DAESUNG MAREF CO.,LTD. | N/A |
| Environment of use | Clinic and hospital | Hospital or home use | Identical |
| Rx or OTC | Rx | Rx | Identical |
| Product code | IRP | IRP | Identical |
| Regulation number | 21CFR 890.5650 | 21CFR 890.5650 | Identical |
| Class | Class II | Class II | Identical |
| Mode of Compression | Sequential/Squeeze/Flush/Flow/Release/Wave | Sequential | Similar |
| Indications for use | Compression Therapy Device (Model: LGT-2210DS) is intended for use Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post-mastectomy lymphedema). Compression Therapy Device (Model: LGT-2210DS) is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in clinical and hospital. The compression Therapy Device (Model: LGT-2210DS) is designed to be used in patients over 22 years old. | MK300L is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema. | Similar Note 1 |
| Treatment area | Arm/Leg | Arm/Leg/Full Body | Identical |
| Sleeve Type | 6-Chamber Leg/Arm Sleeve; 4-Chamber Leg/Arm Sleeve; | 6-Chamber Leg/Arm Sleeve Full body Sleeve (Optional) | Identical |
| Treatment time | 1-120 min | 1-90 min | Similar Note 2 |

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| Pressure ranges | 7.5-187 mmHg | 10-200 mmHg | Similar Note 3 |
| --- | --- | --- | --- |
| Product Dimension (WxLxH) | 385x348x185 mm | 415x310x160 mm | Similar Note 4 |
| Weight | 10.0 Kg | 6.5 Kg | Similar Note 4 |
| Power source | AC 100-120V, 60 Hz | AC 220-230V, 50/60Hz | Similar Note 5 |
| Treatment Modes | 4-Chamber mode: There are 10 modes of M1-M10, among in which M1-M4 and M8-M10 have gradient pressure. 6-chamber mode: There are 10 modes of M1-M10, among in which M1-M5 and M9-M10 have gradient pressure. | A mode (Wave mode by 1 chamber): The selected air chamber(s) inflate(s) and deflates by one chamber sequentially up to thigh from foot B mode (Squeezing mode): After all the selected air chamber(s) inflate(s) sequentially up to thigh from foot, the inflated chambers at once. C mode (B mode two times + Reversed A mode 1 time): It repeats that B mode operates two times and A mode operates reversely one time. | Similar Note 6 |
| Software/firmware/ microprocessor control | Microprocessor | Microprocessor | Identical |
| Electrical Safety | 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 | Identical |
| Safety feature | Power button on main unit or hand switch allows user to stop therapy session at any time | There is a safety switch for emergency to make stop working during operation. | Identical |
| Technology | Compressor and valve system which sequentially inflates inflatable chambers | Compressor and valve system which sequentially inflates inflatable chambers | Identical |
| Environmental Conditions of Operation | Temperature: 5 to 40 °C Rel. humidity: ≤80% Atmosphere Pressure: 62 to 106 | Temperature: 0 to 40 °C Rel. humidity: 10-90 % Atmosphere Pressure: 700- | Similar Note 7 |

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| | kPa | 1060 hPa | |
| --- | --- | --- | --- |
| Environmental Conditions of Transport and Storage | Temperature: -20 to 55 °C
Rel. humidity: ≤93 %
Atmosphere Pressure: 70 to 106 kPa | Temperature: -20 to 60 °C
Rel. humidity: 0-90 %
Atmosphere Pressure: 500 to 1060 hPa | Similar Note 7 |

Note 1: Although there is a little difference about the description of indication for use, the meanings are the same. This difference does not affect the safety and effectiveness.

Note 2: Although the treatment time range of subject device is 1 to 120 min, which seems to be longer than the predicate devices, the default value is 30 min which is suitable for daily use. And the treatment time is optionally set by medical professionals, so the difference of treatment time would not raise adversely impact on safety and effectiveness.

Note 3: Although the pressure range of subject device is different to the predicate devices, the range is smaller and contained by the predicate device, so the difference of pressure range would not raise adversely impact on safety and effectiveness.

Note 4: Although there is a bit difference of the size and weight between the predicate device and subject device, they are all complied with the IEC 60601-1. Thus the differences do not affect the safety and effectiveness.

Note 5: The little difference of the input power and Power consumption does not affect the safety and effectiveness for the predicate device and subject device are complied with the IEC 60601-1. So the differences do not affect the safety and effectiveness.

Note 6: Although the treatment mode of subject device is different to the predicate devices, while the work modes of subject device just have difference about the inflatable order of the different chambers. The treatment pressure ranges are the smaller and contained by the predicate device under different work modes, so the difference of treatment mode would not raise adversely impact on safety and effectiveness.

Note 7: Although the environmental conditions of operation and transport and storage of subject device is different to the predicate devices, the difference of environmental conditions of operation and transport and storage would not raise adversely impact on safety and effectiveness.

Conclusion: The Compression Therapy Device has the same intended use, technology, design and performance specifications are either identical or substantially 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.