K Number

Device Name

Ezlymph, Ezlymph M

Manufacturer

Eezcare Medical Corp

Date Cleared

2021-02-11

(408 days)

Product Code

JOW

Regulation Number

870.5800

Intended Use

EzLymph and EzLymph M are intended to treat lymphedema.

Device Description

EzLymph and EzLymph M is a pump system intended to apply intermittent pneumatic compression (IPC) to arms and legs to relieve the discomfort of lymphedema. The device helps move the flow of lymphatic and venous fluid throughout the extremities by stimulating muscles within the affected extremity. This action mimics natural muscle contractions, improves circulation, and moves excess fluid back to the circulatory system so edema can be eliminated from the body. System components include (a) a mains-powered, portable pneumatic pump with a pressure-control knob and on/off switch (the device contains no control panel or microprocessor circuit); (b) connecting air hoses; and (c) compression garments attached to patient limbs. In addition, garment inserts allow increase in circumference of arm and leg garments. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's upper and lower limbs (full arm, full leg, and half leg).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K910188

Reference Devices

K170216

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it contains "no control panel or microprocessor circuit," and there are no mentions of AI, DNN, or ML in the summary.

Therapeutic

Yes
The device is intended to treat lymphedema and relieve its discomfort, which are therapeutic actions. It also acts by stimulating muscles, improving circulation, and moving excess fluid to eliminate edema from the body, all of which are therapeutic effects.

Diagnostic

The device description clearly states its purpose is to "treat lymphedema" by applying intermittent pneumatic compression, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components: a pneumatic pump, connecting air hoses, and compression garments. It also mentions electrical safety and EMC testing, which are relevant to hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "treat lymphedema" by applying intermittent pneumatic compression to arms and legs. This is a therapeutic treatment applied directly to the patient's body.
Device Description: The device is a pump system that applies physical pressure to the limbs. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.

In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device is a physical therapy device used for treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

EzLymph and EzLymph M are intended to treat lymphedema.

Product codes (comma separated list FDA assigned to the subject device)

JOW

Device Description

EzLymph and EzLymph M is a pump system intended to apply intermittent pneumatic compression (IPC) to arms and legs to relieve the discomfort of lymphedema (see image of device in Figure 1 below).
The device helps move the flow of lymphatic and venous fluid throughout the extremities by stimulating muscles within the affected extremity. This action mimics natural muscle contractions, improves circulation, and moves excess fluid back to the circulatory system so edema can be eliminated from the body.

System components include (a) a mains-powered, portable pneumatic pump with a pressure-control knob and on/off switch (the device contains no control panel or microprocessor circuit); (b) connecting air hoses; and (c) compression garments attached to patient limbs. In addition, garment inserts allow increase in circumference of arm and leg garments.

The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's upper and lower limbs (full arm, full leg, and half leg).

EzLymph and EzLymph M is intended for home use under the care of personnel authorized and trained to treat lymphedema. The device is intended for patients at risk for the medical condition. The system is portable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Arm/Leg

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home use under the care of personnel authorized and trained to treat lymphedema.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:
EzLymph and EzLymph M passed the following non-clinical tests, all of which were performed to current FDA-recognized standards:

Electrical Safety... IEC 60601-1:2005, Mod
EMC... IEC 60601-1-2:2014
Usability Engineering... IEC 62366-1:2015
Risk Management... ISO 14971:2007
Home Healthcare... IEC 60601-1-11:2015

The device passed pump functionality testing and garments pressure cyclic testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K910188

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K170216

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

February 11, 2021

Eezcare Medical Corp % John Gillespy President FDA 510k Consultants, LLC 1100 Del Lago Cir, Ste 104 Palm Beach Gardens, Florida 33410

Re: K193662

Trade/Device Name: Ezlymph, Ezlymph M Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 7, 2021 Received: January 11, 2021

Dear John Gillespy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Fernando Aguel 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

Indications for Use

510(k) Number (if known) K193662

Device Name EzLymph and EzLymph M

Indications for Use (Describe)
--------------------------------

EzLymph and EzLymph M are intended to treat lymphedema.
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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Section 5 – 510(k) Summary

| | 1. 510(k) Submitter: | Eezcare Medical Corp
No. 3-1, Minquan St., New Taipei City 236
Taipei, Tu-Cheng District, Taiwan 23679
Phone: 757-224-0177
Email: michelle.mitchell@eezcare.com.tw | | |
|--|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--|
| | 2. Company Contact: | Michelle C. Mitchell | | |
| | 3. Date of Submission: | December 29, 2019 | | |
| | 4. 510(k) Preparer: | John F. Gillespy, MBA
FDA 510k Consulting, LLC
Palm Beach Gardens, FL 33410
Phone: 386-243-4332
Email: john@fda510kconsultants.com | | |
| | 5. Device Classification: | Trade name:
Common name:
Device:
Class:
Product Code: | EzLymph, EzLymph M
Lymphedema Pump System
Sleeve, Limb, Compressible
II
JOW | |
| | 6. Predicate: | Applicant:
Device:
510(k) Number: | ArjoHuntleigh AB (Sweden)
Hydroven 3 Pump, Hydroven FPR
Pump, Hydroven Garments
K910188 | |
| | Reference: | Applicant:
Device:
510(k) Number: | Tactile Medical
Flexitouch System
K170216 | |

1. Device Description... EzLymph and EzLymph M is a pump system intended to apply intermittent pneumatic compression (IPC) to arms and legs to relieve the discomfort of lymphedema (see image of device in Figure 1 below).
  The device helps move the flow of lymphatic and venous fluid throughout the extremities by stimulating muscles within the affected extremity. This action mimics natural muscle contractions, improves circulation, and moves excess fluid back to the circulatory system so edema can be eliminated from the body.

to patient limbs. In addition, garment inserts allow increase in circumference of arm and leg garments.

1. Mechanism of Action... Intermittent pneumatic compression of air inflates and deflates cuffs attached to affected extremities.
1. Indications For Use... Intended to treat lymphedema.

The device is intended for prescription use only.

Image /page/4/Picture/6 description: The image shows an EzLymph pump and garments. The pump is white with a blue panel and a timer dial. The garments are gray with orange trim and have tubes attached to them. The garments appear to be for legs.

10. Comparison To Predicate & Reference Devices

The subject and predicate devices share the same:

Intended use – To apply intermittent pneumatic compression to arms and legs to relieve the discomfort of lymphedema.
Indications for use – To treat lymphedema (the predicate also claims other indications, as noted in Table 5).
System design - Portable pump, air hoses, compression garments.
Number of models – Two.
Garment styles - Arm, leg.
Compression methods – Uniform, sequential.
Compression cycle lengths - 180 seconds.
Air chambers - Single chamber, multiple chamber.
Multiple garments – Both devices allow treatment with 2 garments.
Mode of operation - Continuous.
Energy sources - Mains power.
Materials – ABS plastic (pump case) and biocompatible fabric (garments).
Reusability – Reusable pump and air tubing; garments are single-patient use.

Minor differences between the subject and predicate devices include:

Number of compression chambers – While both offer single- and multiple-chamber models, for the latter the subject provides 4 chambers compared to the predicate's 3 chambers.
Compression cycle sequence – Both offer 180-second cycles except that the predicate increases cycle length to 120 seconds for cycles that include calf or thigh; since application is continuous over long time periods (days and weeks, not hours or minutes), this difference is immaterial.

The reference device demonstrates substantial equivalence for one physical characteristic, pressure range, for EzLymph.

Characteristics	Subject Device	Predicate Device¹	SE Comparison
Device Name	EzLymph, EzLymph M	Hydroven 3 Pump,
Hydroven FPR Pump,
Hydroven Garments	NA
Manufacturer	Ezcare Medical Corp
(Taiwan)	ArjoHuntleigh AB
(Sweden)	NA
Estab Registration #	3003801933	3007420694	NA
510k Number	Applied For	K910188	NA
Device Photo (Pump
& Air Hoses)	Image: EzLymph pump and air hoses	Image: Hydroven 3 pump and air hoses	SE--both portable pumps
Device Photo
(Calf/Thigh
Garment)	Image: EzLymph calf/thigh garment	Image: Hydroven calf/thigh garment	SE--same basic design
Class	II	II	SE
Regulation #	870.5800	870.5800	SE
Product Code	JOW	JOW	SE
Common Description	Lymphedema Pump	Lymphedema Pump	SE
Medical Specialty	Cardiovascular	Cardiovascular	SE
Submission Type	510(k)	510(k)	SE
Intended Use	To apply intermittent
pneumatic compression to
arms and legs to relieve the
discomfort of lymphedema.	To apply intermittent
pneumatic compression to
arms and legs to treat
conditions listed in IFU.	SE--subject intended use is
subset of predicate's
Indication For Use	EzLymph & EzLymph M are
intended to treat
lymphedema.	Intermittent Pneumatic
Compression (IPC) is effective
in treatment of following
clinical conditions, when
combined with an
individualized monitoring
program: Edema (dependent
& traumatic), Lymphedema,
(primary and secondary),
Chronic venous insufficiency,
Post phlebotic syndrome,
and Acute & chronic wounds
including venous leg ulcers &
post-surgical wounds. IPC
may also be beneficial in
management of: Fixed flexion
deformity, Arthritic
conditions, Lower limb pain
due to trauma or surgery,
and Lipedema. Selection
should be based upon a
holistic assessment of
patients' individual care
needs.	SE--subject intended use
(and IFU) is subset of
predicate's
Target Population	Sufferers of lymphedema	Sufferers of lymphedema
or other clinical conditions
listed in IFU	SE--subject intended use is
subset of predicate's
Anatomical Site	Arm/Leg	Arm/Leg	SE
Where Used	Home	Home	SE
Rx/OTC/Both	Rx Only	Rx Only	SE
Physical Characteristics -- Overall
System Description	Portable pump, connecting
air hoses, & compressible
limb sleeves	Portable pump,
connecting air hoses, &
compressible limb sleeves	SE
Working Principle	Pneumatic pump supplies
compressed air to inflate
compression garments
attached to patient limbs	Pneumatic pump supplies
compressed air to inflate
compression garments
attached to patient limbs	SE

Garment Styles	Full Arm, Half Leg, Full Leg	Full Arm, Half Leg, Full Leg	SE
Garment Sizes	EzLymph--Arm (S,M), Leg
(Half,S,M,L);
EzLymph M--Arm (S,M), Leg
(Half,S,M,L)	Hydroven 3-- Single-
Chamber Arm (4 lengths),
Leg (6 lengths); Triple-
Chamber Arm (2 lengths),
Leg (6 lengths);
Hydroven FPR (all triple-
chamber)--Arm (2
lengths), Leg (6 lengths).	SE--both offer multiple
arm and leg sizes
Garment Inserts	Allow increase in
circumference of arm and
leg garments.	Allow increase in
circumference of arm and
leg garments.	SE
Number of Air
Chambers (Bladders)	EzLymph--1 (arm, leg) and 4
connected bags (arm, leg);
EzLymph M--4 independent
bags (arm, leg)	Hydroven 3--1 (arm, leg) &
3 connected bags (arm,leg);
Hydroven FPR -- 3 indepen-
dent bags (arm, leg).	SE--minor difference in
number of chambers
Compression --
Uniform	EzLymph (1 & 4-chamber
garments) -- Inflate 90 sec,
then deflate 90 sec. Cycle
time 180 sec.	Hydroven 3 (1-chamber
garments) -- Inflate 90 sec,
then deflate 90 sec. Cycle
time 180 sec.	SE
Compression --
Sequential	EzLymph M (4-chamber)--
Inflate sequentially from
distal (120, 90, 60, & 30 sec
respectively), with 10%
pressure decrease with
each subsequent chamber
moving up garment. Then
deflate from proximal (60
sec). Cycle time 180 sec.	Hydroven 3 & FPR (3-
chamber) -- Inflate
sequentially from distal
(114, 76, & 38 sec). Then
deflate from proximal (66
sec). Cycle time 180 sec.	SE--minor difference in
number of chambers
Multiple Garments	2 garments can be used by
alternating for every 90 sec.
Cycle time is 180 sec
(EzLymph only).	2 garments can be used by
alternating for every 90
sec. Cycle time is 180 sec
(Hydroven 3 only).	SE
Mode of Operation	Continuous	Continuous	SE
Pressure Range	EzLymph: 30-75 mmHg +/-
10%
EzLymph M: 30-90 mmHg
+/- 10%	Predicate: 30-100 mmHg
+/- 5%
Reference: 30-75 mmHg	EzLymph: SE--minor
difference w/reference
EzLymph M: SE--minor
difference w/predicate
Physical Characteristics -- Pump
Dimensions (mm)	280L x 140W x 70H	270L x 150W x 105H
(Hydroven 3) or 130H
(FPR)	SE--minor difference
Weight	1.7 kg (3.75lb)	2.4 kg (5.3 lb)	SE--minor difference
Energy Source
(Mains)	AC 100V-230V (60/50 Hz)	AC 120V (60 Hz)	SE--minor difference
Fuse Rating	1A 250V/T1A 250V	F500 mAH 250V	SE--minor difference

Table 5 - Comparison Table

1 Comparison data for the reference device, Flexitouch (K170216), is shown in "Pressure Range" characteristic on Page 5.0-5.

Physical Characteristics--Compression Garment

Ingress Protection	IP21	IPX0	SE--minor difference
Control Panel	Mechanical	Not provided	SE
Operating Temp	5C to 40C	10C to 40C	SE--minor difference
Storage/Transport	-20C to 70C	-20C to 50C	SE--minor difference
Relative Humidity