MedHealth DVT compression Devices MHH900S/MHH900E

K231801 · Medhealth Medical Limited · JOW · Dec 14, 2023 · Cardiovascular

Device Facts

• Record ID: K231801
• Device Name: MedHealth DVT compression Devices MHH900S/MHH900E
• Applicant: Medhealth Medical Limited
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MedHealth DVT Compression Devices MHH900S and MHH900E are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

Device Story

External pneumatic compression (EPC) device; consists of air pump and soft pliable compression garment (foot, calf, or thigh). Controller delivers preset inflation/deflation cycles (12s inflation, 48s deflation) at 40 mmHg (leg) or 120 mmHg (foot). Air pressure transfers to extremity to augment venous blood flow, reduce stasis, and stimulate fibrinolysis. Used in clinical settings; operated by healthcare personnel. Reusable device. Benefits patient by reducing risk of DVT and pulmonary embolism.

Clinical Evidence

No clinical data. Bench testing only, including software validation, cleaning/disinfection validation (AAMI TIR12, ASTM F3208, AAMI ST98), electrical safety/EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC TR 60601-4-2), shelf-life/aging (ASTM F1980), and functional performance (pressure accuracy, cycle timing, burst testing, leakage testing).

Technological Characteristics

Class II EPC device. Powered by AC 100-240V or internal Li-ion battery (14.4V). Intermittent pneumatic compression principle. Applied parts: garments and air tubes. Dimensions: 8.6" x 6.2" x 8.98"; Weight: 2.48 kg. Class I Type BF. Software-controlled timing cycles.

Indications for Use

Indicated for at-risk patients requiring prevention of deep vein thrombosis (DVT) following surgeries such as orthopedics. Contraindications include severe congestive cardiac failure, severe arteriosclerosis or ischemic vascular disease, extreme limb deformity, known or suspected DVT, and local conditions where garments interfere (gangrene, dermatitis, untreated/infected wounds, recent skin grafts).

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 Manufacturing Ltd. Deep Vein Thrombosis (DVT) compression device MHH800 (K200154)

Submission Summary (Full Text)

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December 14, 2023

MedHealth Medical Limited Steven Jiang General Manager 701/101, BLDG 24, Block B, Yuanshan Zone Shangcun, Gongming Shenzhen, Guangdong 518106 China

### Re: K231801

Trade/Device Name: MedHealth DVT compression Devices MHH900S/MHH900E Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 1, 2023 Received: June 20, 2023

### Dear Steven Jiang:

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.

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).

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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 OS 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 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-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 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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Eric E. Richardson -STDV

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K231801

Device Name

MedHealth DVT compression Devices MHH900S/MHH900E

Indications for Use (Describe)

MedHealth DVT Compression Devices MHH900S/MHH900E are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

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) Submission

MHH900S/MHH900E DVT Compression Devices

# 510(k) Summary [As required by 21 CFR 807.92]

- 1. Date Prepared [21 CFR807.92 (a) (1)] Nov 21,2023
- 2. Submitter's Information [21 CFR807.92 (a) (1)] Name of Sponsor: MedHealth Medical Limited

Address: 701/101, BLDG 24, Block B, Yuanshan Zone, Shangcun, Gongming, Shenzhen, 518106, China Contact Name: Steven Jiang Telephone No.: [phone] Fax No.: [phone] Email Address: [e-mail]

### 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]

Trade Name/Model: MedHealth DVT compression Devices MHH900S/MHH900E Common Name, MHH900S/MHH900E DVT Pumps Classification Name: Sleeve, Limb, Compressible Regulation Number: 21 CFR 870.5800 Product code: JOW Classification Panel: Cardiovascular Device Class: Class II

### 4. Identification of predicated Device (S) [21 CFR807.92 (a) (3)]

The predicate device is B&J Manufacturing Ltd. Deep Vein Thrombosis (DVT) compression device MHH800 (K200154)

### 5. Description of the Device [21 CFR807.92 (a) (4)]

The Deep Vein Thrombosis (DVT) Pumps MHH900S and MHH900E are external pneumatic compression (EPC) devices that aid in the prevention of DVT from a potentially life-threatening condition which can lead to pulmonary embolism. MHH900S and MHH900E are non-invasive mechanical prophylactic devices function as secondary

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#### 510(k) Submission

pumps to propel venous blood for patients whose deep vein thrombosis must be prevented after surgeries in Orthopedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.

The two devices separately consist of an air pump and a soft pliable compression garment(s) (Purchased separately) for the foot, calf, or thigh. For MHH900S and MHH900E, the controller supplies compression on a preset timing cycle (12 seconds inflation and maintenance followed by 48 seconds of deflation) at a suggested pressure setting of 40 mmHg for the Leg and 120mmHg for the Foot. The pressure in the qarments is transferred to the extremity, augmenting venous blood flow when the leg is compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clot formation.

The DVT pumps produce automatically timed cycles of compressed air. This compressed air forces blood out of the deep veins, helping to prevent slowed or stopped blood flow. Bursts of air are delivered to the specially designed garments wrapped around extremities. This air helps to move blood out of the deep veins and reduce the risk of developing DVT.

#### 6. Intended Use [21 CFR807.92 (a) (5)]

MedHealth DVT Compression Devices MHH900S and MHH900E are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

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510(k) Submission

# 7. Technological Characteristics [21 CFR807.92 (a) (6)]

# MHH900S DVT Pump

| General Specification: | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Model No. | MHH900S | |
| Size | 8.6" (L) x 6.2" (W) x 8.98" (H) | |
| Weight | 2.48 kg | |
| Pressure Range | Calf/Thigh Garment: 40 mmHg +10/-5mmHg<br>Foot Garment: 120mmHg +10/-5mmHg | |
| Input Rating | AC 100V-240V 50/60Hz 1A | |
| Fuse Rating | 1A or T1AH 250V | |
| Classification | Class I Type BF<br>Not AP or AGP type | |
| Humidity | Operation: 30% to 80 %<br>Storage & Transportation: 30% to 93% | |
| Air pressure | 75 - 106KPA | |
| Temperature | Operation: 5° C- 40° C<br>Storage & Transportation: 5° C - 55° C | |
| Cycle Time | Inflation 12 seconds +/- 1 second<br>Deflation 48 seconds +/- 2 seconds | |
| Applied Part | Garments (Purchased separately) and Air Tube | |
| Battery | Battery pack: 4 x series Li-ion battery cell<br>Battery pack capacity: 2900mAh (Nominal),<br>2700mAh (minimum)<br>Nominal voltage: 14.4V<br>Temperature: Operation 5°C ~ 40°C Storage 5°C ~ 55°C | |
| Garment for the DVT Pump (Purchased separately) : | | |
| Model Name | Applied Part | Specification |
| 801P | Calf | Small, for calf circumference up to 14" (35 cm) |
| 801M | Calf | Medium, for calf circumference up to 18" (45 cm) |
| 801L | Calf | Large, for calf circumference up to 24" (61 cm) |
| 801B | Calf | Extra Large, for calf circumference up to 32" (81 cm) |
| 820M | Foot | Medium, for foot sizes up to 13" |
| 820L | Foot | Large, for foot sizes up to 16" |
| 830S | Full-Leg | Small, for thigh circumference up to 22" (55 cm) |
| 830M | Full-Leg | Medium, for thigh circumference up to 29" (73 cm) |
| 830L | Full-Leg | Large, for thigh circumference up to 36" (91 cm) |
| 830B | Full-Leg | Extra Large, for thigh circumference up to 42" (106 cm) |
| Air Hose Extension for the DVT Pump: | | |
| 810 | | Air hose extension of 59" (Pair) |
| 810L | | Air hose extension of 118" (Pair) |

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510(k) Submission

| General Specification: | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model No. | MHH900E |
| Size | 8.6" (L) x 6.2" (W) x 8.98" (H) |
| Weight | 2.48 kg |
| Pressure Range | Calf/Thigh Garment: 40mmHg +10/-5mmHg<br>Foot Garment: 120mmHg +10/-5mmHg |
| Input Rating | AC 100V-240V 50/60Hz 1A |
| Fuse Rating | 1A or T1AH 250V |
| Classification | Class I Type BF<br>Not AP or AGP type<br>Image: [Person Symbol] |
| Humidity | Operation: 30% to 80 %<br>Storage & Transportation: 30% to 93% |
| Air pressure | 75 - 106KPA |
| Temperature | Operation: 5° C- 40° C<br>Storage & Transportation: 5° C - 55° C |
| Cycle Time | Inflation 12 seconds +/- 1 second<br>Deflation 48 seconds +/- 2 seconds |
| Applied Part | Garments (Purchased separately) and Air Tub |
| Battery | Battery pack: 4 x series Li-ion battery cell<br>Battery pack capacity: 2900mAh (Nominal),<br>2700mAh (minimum)<br>Nominal voltage: 14.4V<br>Temperature: Operation5°C ~ 40°C Storage 5°C ~ 55°C |
| Garment for the DVT Pump (Purchased separately) : | |
| Model Name | Applied Part Specification |
| 801P | Calf Small, for calf circumference up to 14" (35 cm) |
| 801M | Calf Medium, for calf circumference up to 18" (45 cm) |
| 801L | Calf Large, for calf circumference up to 24" (61 cm) |
| 801B | Calf Extra Large, for calf circumference up to 32" (81 cm) |
| 820M | Foot Medium, for foot sizes up to 13" |
| 820L | Foot Large, for foot sizes up to 16" |
| 830S | Full-Leg Small, for thigh circumference up to 22" (55 cm) |
| 830M | Full-Leg Medium, for thigh circumference up to 29" (73 cm) |
| 830L | Full-Leg Large, for thigh circumference up to 36" (91 cm) |
| 830B | Full-Leg Extra Large, for thigh circumference up to 42" (106 cm) |
| Air Hose Extension for the DVT Pump: | |
| 810 | Air hose extension of 59" (Pair) |
| 810L | Air hose extension of 118" (Pair) |

# MHH900E DVT Pump

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510(k) Submission

MHH900S/MHH900E DVT Compression Devices

### 8. Substantial Equivalence [21 CFR807.92 (a) (3) and 807.92]

### 8.1 Intended uses:

### Table 1 Intended Use Comparison

| ID | Comparison<br>Item | Proposed Device<br>MedHealth<br>DVT<br>Compression Devices<br>(MHH900S/MHH900E) | Predicate Device<br>B&J DVT Compression<br>Device<br>(MHH800) |
|----|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510(K) No. | To be assigned | K200154 |
| 2 | Intended<br>Use | The MedHealth Medical<br>Limited. MHH900S and<br>MHH900E Deep Vein<br>Thrombosis (DVT)<br>Compression Devices are<br>intended to increase venous<br>blood flow in at risk patients<br>in order to help prevent deep<br>vein thrombosis. | The B&J Manufacturing Ltd.<br>MHH800 Deep Vein<br>Thrombosis (DVT)<br>Compression Devices are<br>intended to increase venous<br>blood flow in at risk patients<br>in order to help prevent deep<br>vein thrombosis. |
| 3 | Type of use | Prescription Use | Prescription Use |
| 4 | Single use | Reusable | Reusable |

It is clear that the intended use of MHH900S and MHH900E is same as the predictive device

MHH800

### 8.2 Comparison table

## Table 2 General Comparison between MHH900S and MHH800

| ID | Comparison<br>Item | Proposed Device<br>MedHealth DVT<br>Compression<br>Device (MHH900S) | Predicate Device<br>B&J DVT<br>Compression<br>Device (MHH800) | Explanation<br>of Difference |
|-----|-----------------------|---------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 5 | General Specification | | | |
| 5.1 | Size | 8.6"x6.2"x8.98" | 6.5"x7.0"x12.8" | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence |

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| MHH900S/MHH900E DVT Compression Devices | | | | | 510(k) Submission |
|-----------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 5.2 | Weight | 2.48kg | 2. 1kg | | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence |
| 5.3 | Pressure Range | Calf/Thigh:40mmHg;<br>Foot:120mmHg | Calf/Thigh:40mmHg;<br>Foot:120mmHg | | Same |
| 5.4 | Input Rating | AC 100-240V,<br>50/60Hz | AC 100-240V,<br>50/60Hz | | Same |
| 5.5 | Fuse Rating | 1A or T1AH 250V | 1A or T1AH 250V | | Same |
| 5.6 | Classification | Class I Type BF<br>Not AP or AGP<br>type | Class I Type BF<br>Not AP or AGP<br>type<br>Image: Man in doorway | | Same |
| 5.7 | Operation<br>Humidity | 30-80% | 30-75% | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence | |
| 5.8 | Storage &<br>Transportation<br>Humidity | 30-93% | 30-75% | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence | |
| 5.9 | Operation<br>Temperature | 5 ° C-40 ° C | 15 ° C-35 ° C | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence | |
| 5.10 | Storage &<br>Transportation<br>Temperature | 5 ° C-55 ° C | 5 ° C-60 ° C | Different but<br>does not raise<br>any new issue<br>of substantial<br>equivalence | |
| 5.11 | Applied Part | Garment(Purchased separately) and Air Hose | Garment(Purchased separately) and Air Hose | Same | |
| 5.12 | Applied Mode<br>of Pressure | Intermittent | Intermittent | Same | |
| 5.13 | Number of<br>Chambers in<br>Garment | No | No | Same | |
| 5.14 | Inflation<br>chamber<br>(Calf/Thigh) | 12 seconds | 12 seconds | Same | |
| 5.15 | Deflation time<br>per chamber<br>(Calf/Thigh) | 48 seconds | 48 seconds | Same | |
| 5.16 | Inflation time per<br>chamber (Foot) | 12 seconds | 12 seconds | Same | |
| 5.17 | Deflation time<br>per chamber<br>(Foot) | 48 seconds | 48seconds | Same | |
| 5.18 | Pressure<br>Range<br>Calf/ Thigh | 40mmHg | 40mmHg | Same | |
| 5.19 | Pressure Range<br>Foot | 120mmHg | 120mmHg | Same | |
| 5.20 | Pre- Programme<br>d Controls | Yes | Yes | Same | |
| 5.21 | Battery Pack | Yes | Yes | Same | |
| 5.22 | Garments | Purchased separately,<br>listed<br>in<br>510(K)<br>K201532 & K201547 | Purchased separately,<br>listed<br>in<br>510(K)<br>K201532 & K201547 | Same | |
| 5.23 | Contraindications<br>for Use | • Severe<br>congestive cardiac<br>failure.<br>• Severe<br>arteriosclerosis or<br>other ischemic<br>vascular disease.<br>• Extreme<br>deformity of the<br>limbs.<br>• Known or<br>suspected deep<br>vein thrombosis.<br>• Any local<br>condition in which<br>the garments would<br>interfere:<br>1) Gangrene<br>2) Dermatitis<br>3)Untreated or<br>infected wounds<br>4)Recent skin<br>grafts | - Severe congestive<br>cardiac failure.<br>- Severe<br>arteriosclerosis or<br>other ischemic<br>vascular disease.<br>- Extreme deformity<br>of the limbs.<br>- Known or<br>suspected deep vein<br>thrombosis.<br>- Any local condition<br>in which the<br>garments would<br>interfere:<br>- Gangrene<br>- Dermatitis<br>- Untreated or<br>infected wounds<br>- Recent skin grafts | Same | |

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510(k) Submission

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510(k) Submission

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510(k) Submission

Table3 General Comparison between MHH900E and MHH800

| ID | Compariso<br>n Item | Proposed Device<br>MedHealth<br>DVT<br>Compression<br>Device<br>(MHH900E) | Predicate Device<br>B&J DVT<br>Compression<br>Device<br>(MHH800) | Explanation of<br>Difference |
|------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 5 | General Specification | | | |
| 5.1 | Size | 8.6"x6.2"x8.98" | 6.5"x7.0"x12.8" | Different but<br>does not raise any<br>new issue of<br>substantial<br>equivalence |
| 5.2 | Weight | 2.48kg | 2.1kg | Different but<br>does not raise any<br>new issue of<br>substantial<br>equivalence |
| 5.3 | Pressure Range | Calf/Thigh:40mmHg;<br>Foot:120mmHg | Calf/Thigh:40mmHg;<br>Foot:120mmHg | Same |
| 5.4 | Input Rating | AC 100-240V,<br>50/60Hz | AC 100-240V,<br>50/60Hz | Same |
| 5.5 | Fuse Rating | 1A or T1AH 250V | 1A or T1AH 250V | Same |
| 5.6 | Classification | Class I Type BF<br>Not AP or AGP<br>type<br>Image: Man in wheelchair | Class I Type BF<br>Not AP or AGP<br>type<br>Image: Man in wheelchair | Same |
| 5.7 | Operation<br>Humidity | 30-80% | 30-75% | Different but does<br>not raise any new<br>issue of<br>substantial<br>equivalence |
| 5.8 | Storage &<br>Transportation<br>Humidity | 30-93% | 30-75% | Different but does<br>not raise any new<br>issue of<br>substantial<br>equivalence |
| 5.9 | Operation<br>Temperature | 5 °C-40 °C | 15 °C-35 °C | Different but does<br>not raise any new<br>issue of<br>substantial<br>equivalence |
| 5.10 | Storage &<br>Transportation<br>Temperature | 5 °C-55 °C | 5 °C-60 °C | Different but<br>does not raise<br>any new issue of<br>substantial<br>equivalence |
| 5.11 | Applied Part | Garment and Air<br>Hose | Garment and Air<br>Hose | Same |
| 5.12 | Applied<br>Mode<br>of Pressure | Intermittent | Intermittent | Same |
| 5.13 | Number of<br>Chambers in<br>Garment | No | No | Same |
| 5.14 | Inflation<br>time per<br>chamber<br>(Calf/Thigh) | 12 seconds | 12 seconds | Same |
| 5.15 | Deflation time<br>per chamber<br>(Calf/Thigh) | 48 seconds | 48 seconds | Same |
| 5.16 | Inflation time per<br>chamber (Foot) | 12 seconds | 12 seconds | Same |
| 5.17 | Deflation<br>time<br>per chamber<br>(Foot) | 48 seconds | 48seconds | Same |
| 5.18 | Pressure<br>Range<br>Calf/Thig<br>h | 40mmHg | 40mmHg | Same |
| 5.19 | Pressure<br>Range<br>Foot | 120mmHg | 120mmHg | Same |
| 5.20 | Pre- Progr<br>ammed<br>Controls | Yes | Yes | Same |
| 5.21 | Battery Pack | Yes | Yes | Same |
| 5.22 | Garments | Purchased separately,<br>listed in 510(K) K201532<br>& K201547 | Purchased separately,<br>listed in 510(K) K201532<br>& K201547 | Same |
| 5.23 | Contraindications for Use | • Severe congestive<br>cardiac failure.<br>• Severe<br>arteriosclerosis or<br>other ischemic<br>vascular disease.<br>• Extreme deformity<br>of the limbs.<br>• Known or suspected<br>deep vein thrombosis.<br>• Any local condition<br>in which the garments<br>would interfere:<br>• Gangrene<br>• Dermatitis<br>• Untreated or<br>infected wounds<br>• Recent skin grafts | - Severe congestive<br>cardiac failure.<br>- Severe<br>arteriosclerosis or other<br>ischemic vascular<br>disease.<br>- Extreme deformity of<br>the limbs.<br>- Known or suspected<br>deep vein thrombosis.<br>- Any local condition in<br>which the garments<br>would interfere:<br>- Gangrene<br>- Dermatitis<br>- Untreated or infected<br>wounds<br>- Recent skin grafts | Same |

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It is cleared that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MHH900S and MHH900E

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### 8.3 Non-clinical testing [21 CFR 807.92(b) (1)]

The following safety and performance test were conducted to assess MHH900S and MHH900E DVT compression Devices.

- A Software validation
- Cleaning and Disinfection validation—Testing was performed to, and passed, the A following standards:
- AAMI TIR12: 2020 Designing, Testing And Labeling Reusable Medical Devices For Reprocessing In Health Care Facilities: A Guide For Medical Device Manufacturers

● ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

● AAMI…