Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical air compression system with a control panel and air pump. There is no mention of AI, ML, or any features that would suggest the use of such technologies. The performance studies focus on electrical safety, biocompatibility, and software validation, not AI/ML performance metrics.

Therapeutic

Yes.
The device is intended for treating various medical conditions such as lymphedema and edema, and it applies air pressure to limbs to relieve symptoms, indicating a therapeutic purpose.

Diagnostic

No

The device description clearly states its purpose is to "relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs." This indicates a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as a main body with an air pump and control panel, air hoses, and various types of sleeves (cuffs). It also mentions internal components like PCB, control panel, air pump (AC motor pump), and distributor (solenoid). This indicates it is a physical medical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the LF-400 device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device as being used for treating conditions like lymphedema and edema by applying external air pressure to limbs. This is a physical therapy or medical device application, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
Device Description: The description details a pressurization system with sleeves and an air pump. This aligns with a physical therapy or medical device used for external treatment, not an IVD which would involve reagents, analyzers, or other components for analyzing biological samples.
Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.

Therefore, the LF-400 is a medical device used for therapeutic purposes, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

LF-400 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.

Product codes

IRP

Device Description

LF400 is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. LF400 comprises 4-step sleeves which move the body fluids through the limbs by evenly applying pressure to the limbs.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

limbs, leg, arm, waist

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professionals and patients at home, who are under medical supervision

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)

The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility testing (ISO10993-5, ISO10993-10)
Electrical safety and performance testing were conducted according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.
Overall Performance Conclusions: All test results were satisfactory.

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

Not Found

Predicate Device(s)

K102320

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are black and are connected to form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 20, 2015

DaeSung Maref Co., Ltd. c/o Mr. Dave Kim 8310 Buffalo Speedway Houston, TX 77025

Re: K150033

Trade Name: LF-400 Compressible Limb Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: March 20, 2015 Received: March 23, 2015

Dear Mr. Kim:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K150033

Device Name

LF-400 Compressible Limb Therapy System

Indications for Use (Describe)

LF-400 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Special 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510k summary prepared: March 20, 2015

I. SUBMITTER

Submitter's Name :	DaeSung Maref Co., Ltd.
Submitter's Address:	298-24, Gongdan-Ro, Gunpo-shi, Gyeonggi-Do
Republic of Korea, 435-862
Submitter's Telephone:	+82-31-459-7200
Contact person:	Jae-Wha Lee / President
Official Correspondent:
(U.S. Designated agent)	Dave Kim (davekim@mtech-inc.net)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988

II. DEVICE

Trade/proprietary name:	LF-400 Compressible Limb Therapy System
Common or Usual Name:	Air Compressible Limb Therapy System
Regulation Name :	Powered Inflatable Tube Massager
Classification:	21 CFR 890.5650 (Product Code: IRP)
Regulatory Class:	II

4

III. PREDICATE DEVICE

1) Primary Manufacturer	: DaeSung Maref Co., Ltd.
Device	: LX7 (V7)
510(k) Number	: K102320 (Decision Date – Mar. 4, 2011)

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

LF400 is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. LF400 comprises 4-step sleeves which move the body fluids through the limbs by evenly applying pressure to the limbs.

NO	Items	Specification
1	Model	LF400
2	Rating Protection Type	Class II, BF-Type Device
3	Usable Place	Indoor
4	Rated Voltage	100 - 127VAC, 50/60Hz
5	Power Consumption	50VA
6	Rated Fuse	3.15A/250V
7	Setting Pressure	Min. Max Pressure Range:20~140mmHg
(unit:5mmHg)
Manufacturer Recommended Pressure
Range: 60~120mmHg
8	Setting Time	5~180 Minutes (unit:5 Min.)
9	Mode	A, B, C, Pre Therapy
10	Dimension	225(W) * 225(D) * 135(H)mm
11	weight	3.5Kg(main system only)

> Device Specification:

5

ゃ Device Identification:
(1) Main Body

Image /page/5/Picture/3 description: The image shows three different views of a medical device. The views are labeled as "Front", "Right", and "Left". The device is white with a light blue accent and has a screen on the front. The front view shows several ports and a handle.

Top

Back

Image /page/5/Picture/6 description: The image shows a medical device with a white and light blue color scheme. The device features a screen, several buttons, and a knob on the front panel. The device also has a compartment on top, and power switches on the back.

(2) Garment(Cuff)
Image /page/5/Figure/8 description: This image shows a leg cuff. The leg cuff is a medical device used to help prevent blood clots in the legs. The image also shows a diagram of the leg cuff, with labels indicating the thigh circumference, leg length, and ankle circumference. The leg cuff is made of a soft, flexible material and is designed to be worn around the leg.

6

Chamber	4 chamber
Pressure	Min. Max Pressure Range:20~140mmHg (unit:5mmHg)
Manufacturer Recommended Pressure Range: 60~120mmHg
Mode	A, B, C, Pre-therapy
Cuff Material	Nylon
Size		Thigh circumference	Ankle circumference	Leg length
	M	50cm	36cm	67cm
	L	62cm	37cm	74cm
	XL	74cm	43cm	79cm
	XXL	79cm	46cm	92cm
	※Tolerance: ± 2cm
Biocompatibility test	ISO10993-5 (Cytotoxicity test)
ISO 10993-10 (LLNA:BrdU-ELISA)
ISO 10993-10 (Animal Skin Irritation test)

	ARM Cuff
Image	Image
Chamber	4 chamber

7

Pressure	Min. Max Pressure Range:20~140mmHg (unit:5mmHg)
	Manufacturer Recommended Pressure Range: 60~120mmHg
Mode	A, B, C, Pre-therapy
Cuff Material	Nylon
Size	Arm circumference Arm's length Arm Cuff 50cm 88cm ※Tolerance: ± 2cm
Biocompatibility test	ISO10993-5 (Cytotoxicity test)
ISO 10993-10 (LLNA:BrdU-ELISA)
ISO 10993-10 (Animal Skin Irritation test)
Hose Image	Image: Black hose
Hose Length	256 CM
Hose Material	PVC

> Device Characteristics

(1) Components

The basic set of Air Compression Therapy System consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and cutoff sleeve (cuff) for leg and its accessories include overlapping sleeve (cuff) for leg, cutoff sleeve (cuff) for arm, overlapping sleeve (cuff) for arm, cutoff sleeve (cuff) for waist and pants sleeve (cuff).

(2) Characteristics of the device

(1) Operation

The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid).

8

PCB consists of user input switch, LED or LCD display and button for pressure control and controls the air pump and solenoid via micro controller.

Air pump is connected to the hose and supplies air to the distributor.

Air distributor supplies the air to each air chamber in order and thus, repeats the inflation

of Chamber 1 → inflation of Chamber 2 → inflation of Chamber 3 → inflation of

Chamber 4 in this order until the end of the set time.

(2) Electric Characteristics
- a. Rated Voltage: AC100-127V~
- b. Rated Frequency: 50/60Hz
c. Power Consumption: 70VA
(3) Protection against electric shock

Class II, Type BF

(4) Safety Measure
- a. Fuse: 3.15A/250V

b. Air pump has a fuse on the circuit to protect against over temperature.

(5) Software
- a. File Name: LF400.c
- b. Version: V1.0
- c. Main features: switch, display, pump, solenoid, pressure control

9

V. Indications For Use:

LF-400 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Model Name	LF400	LX7(V7)
510(k) Number	Not Assigned	K102320
Classification	Class II Device / IRP
(21 CFR 890.5650)	Class II Device / IRP
(21 CFR 890.5650)
Indications for
Use	LF400 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,
Post immobilization edema, Venous
insufficiencies, Lymphedema	LX7(V7) 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, Post
immobilization edema, Venous
insufficiencies, Lymphedema.
Standard	EN ISO 14971
EN 60601-1
EN 60601-1-2	EN ISO 14971
EN 60601-1
EN 60601-2-10
EN 60601-1-2
Contraindicatio
ns	Acute pulmonary edema
Acute thrombophlebitis
Acute congestive cardiac failure
Acute infections
Deep Vein Thrombosis (DVT)
Episodes of Pulmonary embolism
Wounds lesions or tumors at or in
the vicinity of application
Where increased venous and
lymphatic return is undesirable
Bone fractures or dislocations at or in
the vicinity of application	Acute pulmonary edema
Acute thrombophlebitis
Acute congestive cardiac failure
Acute infections
Deep vein thrombosis (DVT)
Episodes of pulmonary embolism
Wounds, lesions, or tumors at or in
the vicinity of application
Where increased venous and
lymphatic return is undesirable
Bone fractures or dislocation at or in
the vicinity of application.
Mode of
Compression	Sequential	Sequential
Mode	3 modes (A,B,C) + Pre-therapy	3 modes

10

description	mode
Power Source	For Pressure Therapy Units
Electricity Supply: 100-127V~,50/60Hz
Electricity consumption:50VA	For Pressure Therapy Units
Electricity Supply: 230 V~,50/60 Hz
Electricity consumption: 50 VA
Therapy Time	5~180 minutes	10min, 20 min, 30min
Maximum and
Minimum
Pressure	Min. Max. Pressure range:
20~140mmHg
Manufacturer recommended
pressure range: 60 ~ 120mmHg	Min. Max. Pressure range :
0-230mmHg
Manufacturer Recommended
pressure range: 60~120mmHg
Number of
Chamber	4 chamber	4 to 8 chamber
Compression
Cycle Time	5~180 minutes	30min
Actual Picture	Image: blue and white medical device	Image: pink medical device

Differences: Note 1. Description on Mode Difference

	Description	Verification Data	Risk Assessment
1	Pre-therapy
Mode is the
new mode.
It's not for
therapy but
for reducing
fatigue by
finishing
therapy
continuously massaging
from
bottom(foot)
to
top(thigh)
and
massaging
from top to
bottom.	A-Mode Time Chart

A-Mode

B-Mode Time Chart

B-Mode

C-Mode Time Chart | Additional
risks not
concerns for
safety and
effectiveness (Refer to
Risk
Management Report) |

11

Image /page/11/Figure/1 description: The image shows two time charts, one for 'A-Mode Pressure Skip' and another for 'Pre-therapy Mode'. Both charts depict pressure variations over time for four chambers, labeled 1-Chamber through 4-Chamber. The 'A-Mode Pressure Skip' chart has a maximum time of 70 seconds, while the 'Pre-therapy Mode' chart has a maximum time of 90 seconds. Each chamber's pressure is represented by a colored shape, with the timing and duration of pressure application varying between the two modes.

Differences: Note2. Description on Time Difference

| Description | Risk
Assessment |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| 1 | |
| The time setting for LX7, the predicate device, was in the unit of 10
min., 20 min., and 30 min. For additional treatment time, if necessary,
the timer had to be reset by the user in every 10, 20 or 30 min.

The time setting for LF-400, the new subject device, is available for 5 ~
180minutes to provide the user more flexible control over the time
setting, shorter or longer interval, than LX-7, the predicate device. A
single treatment time setting of 5~180 minutes for LF-400 is within the
usual treatment time range between 60 min ~ 960 minutes for treating
Lymphedema patients, based on the prescription of a physician. | Additional
risks not
concerns for
safety and
effectiveness
(Refer to Risk
Management
Report) |

12

Differences: Note3. Description on Pressure Difference

| | Description | Risk
Assessment |
|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | The pressure limit for LX7 ranges between 0230mmHg and the
manufacturer recommended pressure range was between 60120mmHg
(see page 13 of LX7 Manual).

The air pressure setting for LF-400, the new subject device, ranges
between 0140mmHg and the recommended pressure range is
identical to 60120 mmHg to be aligned closely with the pressure
setting found in usual Lymphedema treatment cases. In few
Lumphedema treatment cases reported, the air pressure setting applied
to treat Lymphedema patients ranged between 30~160mmHg based on
the severity of the symptoms even though the same report indicated
small number of patients experienced pain or discomfort at the pressure
setting of 160mmHg. | The pressure
range for LF-
400 is smaller
than the one
for LX7.
Additional
risks not
concerns for
safety and
effectiveness
(Refer to Risk
Management
Report) |

Differences: Note4. Description on Fabric Difference

	Description	Verification Data	Risk Assessment
1	LF-400, the
new device,
uses nylon for
the cuffs, same
material used
for LX7(V7).
OXFORD is
the weaving
method of
fabric. It is not
the element of
fabric.	Dictionary definition on “OXFORD”
Noun
Two or three threads are woven in
parallel without being twisted.	The same
fabric for
cuffs is used
for the subject
and predicate
device.
Thus,
Additional
risks not
concerns for
safety and
effectiveness
(Refer to Risk
Management
Report)
2	OXFORD
Composition
Table shows
that the device
is made 100%
with nylon.	OXFORD Composition Table
5407-41-0000 5110 N/210D SD 고 62"
100% NYLON F.YARN WOVEN FABRIC (OXFORD) IN GREY (SD)
62" (WOVEN BY SHUTTLELESS LOOM)
WP : N.F.Y.210D/68
WT : N.F.Y.210D/54
TOTAL WEIGHT : 170GR/YD

13

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility testing (ISO10993-5, ISO10993-10)

Electrical safety and performance testing were conducted according to standard IEC 60601-1: 2005 + CORR.1(2006) + CORR(2007) and EMC testing were conducted in accordance with standard IEC 60601-1-2:2007.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.

Overall Performance Conclusions

All test results were satisfactory.

VII. CONCLUSIONS

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification DaeSung Maref Co, Ltd. concludes that LF-400 Compressible Limb Therapy System is safe and effective and substantially equivalent in comparison with LX7 (V7), the predicate device as described herein.