Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard pneumatic compression device with an air compressor and controller. There is no mention of AI, ML, or any data processing that would suggest such technology is used. The performance studies are based on electrical safety, EMC, and biocompatibility standards, not AI/ML performance metrics.

Therapeutic

Yes.
The device is intended for the temporary relief of minor muscle aches and to temporarily increase circulation to treated areas, which are therapeutic claims.

Diagnostic

No

Explanation: The device's intended use is for temporary relief of muscle aches and temporary increase in circulation, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including an air compressor, inflatable sleeves, a hose, and a main unit body made of ABS plastic, powered by an external supply or internal battery.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Compression Therapy Device LGT-2200SP is a physical therapy device that applies external pressure to the body using inflatable sleeves. It does not analyze any biological samples.
Intended Use: The intended use is for temporary relief of muscle aches and increased circulation, which are physical effects, not diagnostic purposes.

The information provided clearly describes a device that interacts with the body externally for therapeutic purposes, not for analyzing samples to diagnose conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Compression Therapy Device LGT-2200SP is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.

Product codes

IRP

Device Description

Compression therapy device LGT-2200SP is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller, 4-chamber sleeves covered with Polyether Nylon Fabric, and a connectable hose for connecting the device to the sleeves. The case of main unit body is made from ABS plastic

The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 4-chambers and different applicable body areas, such as the Arm' Leg/ Waist, hip and thigh/ Calf and foot. The sleeves can be inflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit.

The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It is to be used by adults who are in good health.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Arm, Leg, Waist, hip, thigh, Calf and foot

Indicated Patient Age Range

Adults

Intended User / Care Setting

Not Found

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)

Compression Therapy Device has been evaluated the safety and performance by lab bench testing according to the following standards:

ANSI/AAMI ES60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005+A1:2012
IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
IEC 60601-1-11, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Edition 2.0 2015-01
IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications- Part 2: Lithium systems
ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Clinical performance is not deemed necessary.

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

Not Found

Predicate Device(s)

K160608, K182668

Reference Device(s)

K161907

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

October 29, 2019

Guangzhou Longest Science & Technology Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN

Re: K191862

Trade/Device Name: Compression Therapy Device Model LGT-2200SP Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: September 1, 2019 Received: September 5, 2019

Dear Jet Li:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.

1

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 (QS) 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.

For Vivek Pinto, Ph.D. Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K191862

Device Name Compression Therapy Device Model: LGT-2200SP

Indications for Use (Describe)

Compression Therapy Device LGT-2200SP is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

1. Submitter Information

Sponsor: GUANGZHOU LONGEST SCIENCE&TECHNOLOGY CO., LTD.

Address: 5&6f, BuildingB4, No.11, Kaiyuan Avenue, Science City Guangzhou Hi-Tech Industrial

Development Zone, Guangzhou Guangdong, CHINA 510530

Contact Person: Xiaobing Luo

Title: Deputy General Manager

Phone: +86-020-66353999 Fax: +86-020-66353920

E-mail: gzlongest@126.com

Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: med-jl @foxmail.com Phone: 86-18588874857 Address: 6F, No.1 TianTairoad, Science City, LuoGang District, GuangZhou City, China

2. Subject Device Information

Type of 510(k) submission: Traditional Common Name: Compression Therapy Device Model: LGT-2200SP Classification Name: Powered inflatable tube massager Review Panel: Physical Medicine Product Code: IRP Regulation Number: 21 CFR 890.5650

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Regulation Class: 2

1. Predicate and Reference Device Information 1) Primary Predicate Device Sponsor: NormaTec Industries Trade/Device Name: NormaTec Pulse and NormaTec Pulse Pro 510K number: K160608 Regulation Number: 21 CFR 890.5650 2) Secondary Predicate Device Sponsor: Rapid Reboot Recovery Products, LLC Device Name: Rapid Reboot Compression Therapy System 510(k) number: K182668 Regulation Number: 21 CFR 890.5650 3) Reference Device Sponsor: XIAMEN SENYANG CO., LTD. Device Name: Pressure Therapy System, model: Pt 1002 510(k) number: K161907 Regulation Number: 21 CFR 890.5650

4. Device Description

Compression therapy device LGT-2200SP is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller, 4-chamber sleeves covered with Polyether Nylon Fabric, and a connectable hose for connecting the device to the sleeves. The case of main unit body is made from ABS plastic

The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 4-chambers and different applicable body areas, such as the Arm' Leg/ Waist, hip and thigh/ Calf and foot. The sleeves can be inflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit.

The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It is to be used by adults who are in good health.

5. Intended Use/Indication for use

5

Compression Therapy Device LGT-2200SP is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.

Test Summary 6.

Compression Therapy Device has been evaluated the safety and performance by lab bench testing according to the following standards:

മ ANSI/AAMI ES60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005+A1:2012
IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic ಡ safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
IEC 60601-1-11, Medical electrical equipment Part 1-11: General requirements for basic x safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Edition 2.0 2015-01
IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid 区 electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications- Part 2: Lithium systems
x ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and X skin sensitization
Guidance for the Content of Premarket Submissions for Software Contained in Medical x Devices.

7. Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness. See the below form.

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Elements of		Predicate Device	Predicate Device	Predicate Device
comparison	Subject Device	(Primary)	(II)	(III)	Verdict
Manufacturer	GUANGZHOU LONGEST
SCIENCE&TECHNOLOGY CO.,
LTD.	NormaTec Industries	Rapid Reboot Recovery Products,
LLC	XIAMEN SENYANG CO., LTD.	--
510K number	TBD	K160608	K182668	K161907	--
Product Name	Compression Therapy Device
LGT-2200SP	NormaTec Pulse and NormaTec
Pulse Pro	Rapid Reboot Compression
Therapy System	Pressure Therapy System, Pt
1002	--
Classification
Name	Pow ered inflatable tube
massager	Pow ered inflatable tube massager	Pow ered inflatable tube massager	Pow ered inflatable tube massager	SE
Regulation
Class	2	2	2	2	SE
Regulation
Number	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	21 CFR 890.5650	SE
OTC & Rx	OTC	OTC	OTC	Rx	--
		Indications for Use
Indications for
Use	Compression Therapy Device
LGT-2200SP is intended for the
temporary relief of minor muscle
aches and pains and for the
temporary increase in circulation
to the treated areas, it can
simulate kneading and stroking
of tissues by using an inflatable
garment.	The NormaTec Pulse and Pulse
Pro is an air pressure massager
intended to temporarily relieve
minor muscle aches and/or pains,
and to temporarily increase
circulation to the treated areas.	The Rapid Reboot Compression
Therapy System is intended for
the temporary relief of minor
muscle aches and pains and for
the temporary increase in
circulation to the treated areas in
people who are in good health.
The Rapid Reboot Compression
Therapy System simulates
kneading and stroking of tissues	The device is indicated for use by
medical professionals and patient
at home, who are under medical
supervision, in treating many
conditions, such as: Primary
lymphedema, edema follow ing
trauma and sport injuries, post
immobilization edema, venous
insufficiencies, lymphedema.	Minor
differen
t
Note 1
Elements of
comparison	Subject Device	Predicate Device
(Primary)	Predicate Device
(II)	Predicate Device
(III)	Verdict
			by using an inflatable garment.
		Device design
Power Source	AC100-240V, 50/60Hz
Battery 11.1V, 6500mAh meet
IEC 62133	12 VDC via an IEC 60601-1
compliant pow er supply (100-240
VAC input)
Optional Integrated rechargeable
battery	110 V, 60Hz	110 V, 60Hz	Minor
different
t
Note 2
Power
consumption	90VA	14W	30W	30W	Minor
different
t
Note 2
Dimensions
(WHD)	270148129mm	4"5" 9"	10" x 6.5" x 5"	260170130mm	Minor
different
t
Note 2
Elements of
comparison	Subject Device	Predicate Device
(Primary)	Predicate Device
(II)	Predicate Device
(III)	Verdict
Photo	Image: Subject Device	Image: Predicate Device (Primary)	Image: Predicate Device (II)	Image: Predicate Device (III)	Minor
different
Note 2
Weight	2.0 Kg(4.4pounds)	3.6 pounds	5.8 pounds	5.8 pounds	Minor
different
Note 2
Housing
Materials	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	SE
Sleeves	4-chamber Arm Sleeve:
97.0*28.7 cm	Leg:	Leg:
X-Short: 14" x 41"
Short: 14" x 43"
Medium: 14" x 45"	Small Leg Cuff:90X30cm
Large Leg Cuff:110X30cm	Minor
different
Elements of
comparison	Subject Device	Predicate Device
(Primary)	Predicate Device
(II)	Predicate Device
(III)	Verdict
	4-chamber Leg Sleeve:
S: $94.2*35.85$ cm
M: $106.2*39.0$ cm
L: $116.0*44.8$ cm

Image: 4-chamber Leg Sleeve | Image: Normatec Arm Sleeve | Long: 14" x 48"
X-Long: 14" x 52"

Image: 4-chamber Waist, Hip and Thigh Sleeve | Hip:

Image: Normatec Hip Sleeve | Hip:
Regular: 26" x 32"
Large: 26" 35"

Image: 4-chamber Calf and Foot Sleeve | | Arm:
Regular: 18" x 38"
Long: 18" x 44"

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8

9

10

11

12

13

Note 1

Although there is a little difference about the cation for use, the meanings are the same. This difference does not affect he safety and effectiveness.

Note 2

Although the subject device design and specification parameter between the predicate are different, they are both complied with ANSVAAM ES60601 -1. So the minor differences on such parance) do not affect the safety and effectiveness.

Note 3

Although the device provides four kind sleeves which have minor difference about size and appearance, the sleeve chamber number are the same and the applicable body areas are included in the predical of sleeves is also complied with ISO 1099-5 and ISO 10993-10. Therefore, the difference would not raise adversely impact on safety and effectiveness.

Note 4

Although the pressure range of subject devices, the range is smaller and contained by the predicate device (1), sothe difference of pressure range would not raise adversely impact on safety and effectiveness.

Note 5

Although the treatment time range of subject device is to 99mins, which seems to be longer than the predicated with is suitable for daily use. And the treatment time is optionally set by userwith 5mins step, which is more exact to the difference of pressure range would not raise adversely impact on safety and effectiveness.

14

Note 6

Although the subject device provides six kinds of work mode, the SEQUENTIAL and FLUSH mode are the same with the other work modes of subject device just have different about the different thambers. The treatment pressure range are the same under different work modes, so the difference of pressure range would not raise adversely impact on safety and effectiveness.

Note 7

The subject device references more sufficient safety standards than the safety of the safety of the device is verified via tests.

7. Summary for clinical test

Clinical performance is not deemed necessary.

8. Conclusion

The subject device Compression Therapy Device has all features for intended use. Thus, the subject device is substantially equivalent to the predicate devices.

9. Summary Prepared Date

21 Oct. 2019