DVT Garment
Device Facts
| Record ID | K253386 |
|---|---|
| Device Name | DVT Garment |
| Applicant | Vistar Medical Supplies Co., Ltd. |
| Product Code | JOW · Cardiovascular |
| Decision Date | Jun 25, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The DVT Garment is a medical device designed to prevent deep vein thrombosis (DVT) and improve blood circulation in the lower extremities. It must be used in conjunction with a compatible DVT therapy machine.
Device Story
DVT Garment is a disposable, single-patient-use compressible limb sleeve; used with a compatible external pneumatic pump system. Device receives pressurized air from the pump to inflate chambers; sequential or intermittent inflation collapses veins to force blood toward the heart; deflation allows venous refill. Used in clinical settings; operated by healthcare professionals. Output is mechanical compression of the limb; aids in DVT prevention by simulating muscle contraction. Benefits include reduced risk of venous stasis and thrombosis.
Clinical Evidence
No clinical data. Bench testing only: dimensions, leakage, lifetime, pressure resistance, tensile strength, and inflation/deflation cycles. Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation) confirmed compliance.
Technological Characteristics
Compression sleeve; materials: white nylon-coated TPU film, non-woven fabric coated with TPU film, PVC air hose, plastic connectors. Energy source: external pneumatic pump. Sequential (3-chamber) or intermittent (1-chamber) modes. Dimensions vary by size (XS-XL). Biocompatibility per ISO 10993 series. Non-electronic, passive mechanical component.
Indications for Use
Indicated for patients at risk of deep vein thrombosis (DVT) requiring improved lower extremity blood circulation; prescription use only.
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
- B&J DVT Calf/Thigh Garments, Models 801/830 Series (K201532)
- B&J DVT Foot Garments, Models 820 Series (K201547)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
June 25, 2026
Vistar Medical Supplies Co., Ltd.
% Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China
Re: K253386
Trade/Device Name: DVT Garment
Regulation Number: 21 CFR 870.5800
Regulation Name: Compressible Limb Sleeve
Regulatory Class: Class II
Product Code: JOW
Dated: May 14, 2026
Received: May 15, 2026
Dear Boyle 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 (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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K253386 - Boyle Wang
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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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253386 - Boyle Wang
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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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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253386 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| DVT Garment | | |
| Please provide your Indications for Use below. | | ? |
| The DVT Garment is a medical device designed to prevent deep vein thrombosis (DVT) and improve blood circulation in the lower extremities. It must be used in conjunction with a compatible DVT therapy machine. | | |
| Please select the types of uses (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---
# 510(k) Summary
**K253386**
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
## 1.0 Submitter's information
Name: Vistar Medical Supplies Co.,Ltd.
Address: 101, 201 &301, No.5 Facility, Datianyang Nansi Rd., Dongfang Community, Songgang Street, Bao'an District, Shenzhen 518105 China
Tel: +86(0)755-85298331
Contact: +86(0)755-85298331
Date of Preparation: June.17, 2026
## Designated Submission Correspondent
Mr. Boyle Wang
Shanghai Truthful Information Technology Co., Ltd.
Address: Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China.
Tel: +86-21-50313932
Email: Info@truthful.com.cn
## 2.0 Device information
Trade name: DVT Garment
Common name: DVT Garment
Classification name: Sleeve, limb, compressible
## 3.0 Classification
Production code: JOW
Regulation number: 21 CFR 870.5800
Classification: Class II
Panel: Cardiovascular
## 4.0 Predicate device information
Predicate Device 1:
Manufacturer: B & J Manufacturing Ltd.
Trade/Device Name: B&J DVT Calf/Thigh Garments, Models 801/830 Series
510(k) number: K201532
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510(k) Summary
Predicate Device 2:
Manufacturer: B & J Manufacturing Ltd.
Trade/Device Name: B&J DVT Foot Garments, Models 820 Series
510(k) number: K201547
## 5.0 Indication for Use Statement
The DVT Garment is a medical device designed to prevent deep vein thrombosis (DVT) and improve blood circulation in the lower extremities. It must be used in conjunction with a compatible DVT therapy machine.
## 6.0 Device description
The DVT Garments are compression devices. When the devices are attached to a pump system, they provide intermittent, sequentially gradient pressure to a patient foot/calf/thigh for the prevention of deep vein thrombosis (DVT).
When the compression sleeve is inflated, the veins collapse which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the foot, calf or thigh. This device is a disposable single patient use products.
The DVT garments are supplied as pairs. The three-chamber garments include one left and one right garment, identified by “L” and “R” respectively. The single-chamber garment is not side-specific.
| Series | Description | Model | Size | Circumference (inch) |
| --- | --- | --- | --- | --- |
| Sequential Garment (3 chambers) | Calf Garment | DVT10C31 | Extra Small | ≤14" |
| | | DVT10C32 | Small | 14"-18" |
| | | DVT10C33 | Medium | 18"-24" |
| | | DVT10C34 | Large | 24"-30 |
| | | DVT10C35 | Extra Large | 26"-35" |
| | Foot Garment | DVT10F31 | Medium | ≤13" |
| | | DVT10F32 | Large | ≤16" |
| | Thigh Garment | DVT10T31 | Extra Small | ≤14" |
| | | DVT10T32 | Small | 14"-20" |
| | | DVT10T33 | Medium | 20"-25" |
| | | DVT10T34 | Large | 25"-30" |
| | | DVT10T35 | Extra Large | 30"-32" |
| Intermittent Garment (1 chamber) | Calf Garment | DVT10C11 | Extra Small | ≤14" |
| | | DVT10C12 | Small | 14"-18" |
| | | DVT10C13 | Medium | 18"-24" |
| | | DVT10C14 | Large | 24"-30 |
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510(k) Summary---
| | Foot Garment | DVT10C15 | Extra Large | 26'-35' |
| --- | --- | --- | --- | --- |
| | | DVT10F11 | Medium | ≤13' |
| | | DVT10F12 | Large | ≤16' |
| | Thigh Garment | DVT10T11 | Extra Small | ≤14' |
| | | DVT10T12 | Small | 14'-20' |
| | | DVT10T13 | Medium | 20'-25' |
| | | DVT10T14 | Large | 25'-30' |
| | | DVT10T15 | Extra Large | 30'-32' |
The subject device is supplied in 2 series:
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510(k) Summary
## 7.0 Technological Characteristic Comparison Table
The subject device DVT Garment is substantially equivalent to the predicate device with respect to the intended use, technology and construction. The differences between the predicate and the subject device are minor and any risks have been mitigated through testing. The below table summarizes the differences between the subject and predicate device.
**Table1-General Comparison between Subject device and Predicate Device K201532**
| Item | Subject device K253386 | | Predicate device 1 K201532 | | Remark |
| --- | --- | --- | --- | --- | --- |
| Trade/Device Name | DVT Garment | | B&J DVT Calf/Thigh Garments, Models 801/830 Series | | / |
| Manufacturer | Vistar Medical Supplies Co.,Ltd. | | B & J Manufacturing Ltd. | | / |
| Class &Code | Class II JOW 870.5800 | | Class II JOW 870.5800 | | Same |
| Intended Use / Indication for Use | The DVT Garment is a medical device designed to prevent deep vein thrombosis (DVT) and improve blood circulation in the lower extremities. It must be used in conjunction with a compatible DVT therapy machine. | | The B&J DVT Calf/Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). | | Same |
| Type of Use | Prescription Use | | Prescription Use | | Same |
| Sequencing | Sequential | Intermittent | Sequential | Intermittent | Same |
| Model, Size and | Calf Garment: | Calf Garment: | Calf Garment: | Calf Garment: | Similar, the |
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510(k) Summary
| Type | DVT10C31, Extra Small, ≤ 14" DVT10C32, Small, 14"-18" DVT10C33, Medium, 18"-24" DVT10C34, Large, 24"-30 DVT10C35, Extra Large, 26"-35" | DVT10C11, Extra Small, ≤ 14" DVT10C12, Small, 14"-18" DVT10C13, Medium, 18"-24" DVT10C14, Large, 24"-30 DVT10C15, Extra Large, 26"-35" | 801PSQ, Small, 14" 801MSQ, Medium, 18" 801LSQ, Large, 24" 801BSQ, Extra Large, 32" | 801P, Small, 14" 801M, Medium, 18" 801L, Large, 24" 801B, Extra Large, 32" | difference doesn't affect the substantial equivalence with the predicate. |
| --- | --- | --- | --- | --- | --- |
| | Thigh Garment: DVT10T31, Extra Small, ≤ 14" DVT10T32, Small, 14"-20" DVT10T33, Medium, 20"-25" DVT10T34, Large, 25"-30" DVT10T35, Extra Large, 30"-32" | Thigh Garment: DVT10T11, Extra Small, ≤ 14" DVT10T12, Small, 14"-20" DVT10T13, Medium, 20"-25" DVT10T14, Large, 25"-30" DVT10T15, Extra Large, 30"-32" | Thigh Garment: 830SSQ, Small, 14" 830MSQ, Medium, 29" 830LSQ, Large, 36" 830BSQ, Extra Large, 42" | Thigh Garment: 830S, Small, 14" 830M, Medium, 29" 830L, Large, 36" 830B, Extra Large, 42" | |
| Material | Outside material: White Nylon coated TPU film, Patient side: White non-woven Fabric coated with TPU film, Air hose: PVC tube, Connector: Plastic. | | Nylon loop, polyurethane foam, polyester tricot, TPU film, PVC tube, nylon velcro, polyester & cotton binding, nylon thread | Nylon loop, polyester loop, polyurethane foam, polyester tricot, PVC film, PVC tube, nylon velcro, polyester & cotton binding, nylon thread | Similar |
| Inflation/deflation cycle times | 11-13 seconds / 48 seconds | | 12 seconds / 48 seconds | 12 seconds / 48 seconds | Similar |
| Pressure ranges | 45, 40, and 30mmHg | | 45, 40, and 30mmHg | 40mmHg | Same |
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510(k) Summary
Table2-General Comparison between Subject device and Predicate Device K201547
| Item | Subject device K253386 | | Predicate device 2 K201547 | | Remark |
| --- | --- | --- | --- | --- | --- |
| Trade/Device Name | DVT Garment | | B&J DVT Foot Garments, Models 820 Series | | / |
| Manufacturer | Vistar Medical Supplies Co.,Ltd. | | B & J Manufacturing Ltd. | | / |
| Class &Code | Class II JOW 870.5800 | | Class II JOW 870.5800 | | Same |
| Intended Use / Indication for Use | The DVT Garment is a medical device designed to prevent deep vein thrombosis (DVT) and improve blood circulation in the lower extremities. It must be used in conjunction with a compatible DVT therapy machine. | | The B&J DVT Foot Garments, Models 820 Series are external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation. | | Same |
| Type of Use | Prescription Use | | Prescription Use | | Same |
| Sequencing | Sequential | Intermittent | Sequential | Intermittent | Same |
| Model, Size and Type | Foot Garment: DVT10F31, Medium, ≤13' DVT10F32, Large, ≤16' | Foot Garment: DVT10F11, Medium, ≤13' DVT10F12, Large, ≤16' | Foot Garment: 820MSQ, Medium, 13' 820LSQ, Large, 16' | Foot Garment: 820M, Medium, 13' 820L, Large, 16' | Similar, the difference doesn't affect the substantial equivalence with the predicate. |
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510(k) Summary
| Material | Outside material: White Nylon coated TPU film, Patient side: White non-woven Fabric coated with TPU film, Air hose: PVC tube, Connector: Plastic. | Nylon loop, polyurethane foam, polyester tricot, TPU film, PVC tube, nylon velcro, polyester & cotton binding, nylon thread | | Similar |
| --- | --- | --- | --- | --- |
| Inflation/deflation cycle times | 11-13 seconds / 48 seconds | 12 seconds / 48 seconds | 12 seconds / 48 seconds | Similar |
| Pressure ranges | ≤130mmHg | 120mmHg+10/-5mmHg | 120mmHg+10/-5mmHg | Analysis |
The subject device has the same intended use, indications for use, technological characteristics, principles of operation, and performance specifications as the predicate device.
#### Analysis:
All differences between the subject device and the predicate devices (including material composition, pressure parameter range, and inflation/deflation cycle control mode) are either 'optimizations for functional flexibility' (e.g., adaptive inflation/deflation cycles) or 'upgrades for material performance' (e.g., TPU film replacing PVC film). These differences do not change the working principle (simulating muscle contraction through intermittent/sequential pressure) or key performance indicators (pressure accuracy, airtightness, material biocompatibility) of the device, nor do they introduce new safety risks (such as skin irritation, structural rupture, or pressure overload).
Despite of the above differences, the two devices all completed the performance tests. In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device 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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510(k) Summary
## 8.0 Summary of Non-Clinical Testing
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 performance testing:
- Dimensions/Appearance Test
- Leakage Test
- Lifetime Test
- Pressure Resistance Test
- Tensile Strength Test
- Inflation and Deflation Test
# Biocompatibility of patient-contacting parts
- Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
- Skin Sensitization per ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.
- Skin Irritation per ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests For Irritation.
All tests met the pre-determined acceptance criteria.
## 9.0 Summary of Clinical Testing
No clinical study implemented for the DVT Garment.
## 10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicate devices and raises no new questions of safety or effectiveness.
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