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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Compression Therapy Device Model LGT-2200SP. It asserts substantial equivalence to predicate devices and focuses on technical specifications and adherence to safety standards.

Here's an analysis of the provided text in relation to your request:

The document does not include detailed acceptance criteria or a study that rigorously proves the device meets those criteria in a clinical performance context. Instead, it focuses on demonstrating safety and effectiveness through compliance with recognized standards and comparison to predicate devices.

Let's break down your specific points based on the available information:

A table of acceptance criteria and the reported device performance:
The document doesn't provide a typical "acceptance criteria" table for device performance in a clinical sense (e.g., accuracy, sensitivity, specificity). Instead, it compares the subject device's technical specifications and features to predicate devices, and asserts that differences do not raise new questions of safety or effectiveness.

Here's a table summarizing the comparison of the device's technical specifications and features to the predicate devices, which act as a form of "acceptance" by demonstrating substantial equivalence:

Elements of Comparison	Subject Device (LGT-2200SP)	Predicate Device (Primary: NormaTec Pulse/Pro)	Predicate Device (II: Rapid Reboot System)	Predicate Device (III: Senyang Pt 1002)	Verdict (Equivalence Claim)
Classification Name	Powered inflatable tube massager	Powered inflatable tube massager	Powered inflatable tube massager	Powered inflatable tube massager	Substantially Equivalent (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	Minor different (Noted in Remarks below)
Indications for Use	Temporary relief of minor muscle aches and pains, temporary increase in circulation. Simulates kneading/stroking.	Temporary relief of minor muscle aches/pains, temporary increase in circulation.	Temporary relief of minor muscle aches/pains, temporary increase in circulation in healthy people. Simulates kneading/stroking.	Treating primary lymphedema, edema, venous insufficiencies, lymphedema (Rx use).	Minor different (Noted in Remarks below)
Power Source	AC100-240V, Battery 11.1V, 6500mAh	12 VDC via IEC 60601-1 PSU, Optional rechargeable battery	110 V, 60Hz	110 V, 60Hz	Minor different (Noted in Remarks below)
Power Consumption	90VA	14W	30W	30W	Minor different (Noted in Remarks below)
Dimensions (WHD)	270148129mm	4"5" 9"	10" x 6.5" x 5"	260170130mm	Minor different (Noted in Remarks below)
Weight	2.0 Kg (4.4 pounds)	3.6 pounds	5.8 pounds	5.8 pounds	Minor different (Noted in Remarks below)
Housing Materials	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	SE
Number of Chambers	4-chamber	5 or less	4 Chambers	4 Chambers	SE
Sleeve Materials	Polyether Nylon Fabric	200 denier nylon with polyurethane laminate/extrusion	Nylon with a Polyurethane laminate	Thermoplastic Urethane	Minor different (Noted in Remarks below)
Mode of Compression	Sequential	Sequential	Sequential	Sequential	SE
Device Pressure Range	30-150mmHg	30-110 mmHg	0-200 mmHg	0-250mmHg	Minor different (Noted in Remarks below)
Treatment Time	1min-99min, default 30min, step of 5min	Stays on until user turns off or 10mins to continuous	10, 20, or 30 minute, with option to add 10 minutes	0 - 30mins	Minor different (Noted in Remarks below)
Work Mode	6 modes (SEQUENTIAL, SQUEEZE, FLUSH, FLOW, RELEASE, WAVE)	Sequential, Zone pulses (2 modes)	Model A, Model B (2 modes)	Model A, Model B (2 modes)	Minor different (Noted in Remarks below)
Patient Contact	Non-conductive appliances	Non-conductive appliances	(Image of Predicate II)	(Image of Predicate III)	SE
Software/Firmware/Microprocessor Control	Microprocessor	Microprocessor	Microprocessor	Microprocessor	SE
Technology	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	Compressor and valve system inflates cells of appliance sequentially	SE
FDA-Recognized Standards	ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133, ISO 10993-5, ISO 10993-10	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	IEC 60601-1:2014, IEC 60601-1-2:2014, EN ISO 10993-5:2009, EN ISO 10993-10:2010	IEC 60601-1, IEC 60601-1-2, ISO10993-5, ISO10993-10	Minor different (Noted in Remarks below)

Remarks on "Minor different" Verdicts:

Indications for Use: The document states, "Although there is a little difference about the indication for use, the meanings are the same. This difference does not affect the safety and effectiveness." (Note 1)
Power Source, Consumption, Dimensions, Weight: "Although the subject device design and specification parameter between the predicate are different, they are both complied with ANSI/AAMI ES60601-1. So the minor differences on such parameters do not affect the safety and effectiveness." (Note 2)
Sleeve Materials, Sleeves (dimensions/types): "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 predicate... the biocompatibility 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 3)
Device Pressure Range: "Although the pressure range of subject devices, the range is smaller and contained by the predicate device (1), so the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 4). (There seems to be an error in the text where it ambiguously says "range is smaller and contained by the predicate device (1)" when for PD(II) and PD(III) the subject device's range is within a larger range.)
Treatment Time: "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 user with 5mins step, which is more exact to the difference of pressure range would not raise adversely impact on safety and effectiveness." (Note 5). (There seems to be an error in the text where it mentions "difference of pressure range" instead of treatment time range).
Work Mode: "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 chambers. 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 6).
FDA-Recognized Standards: "The subject device references more sufficient safety standards than the 'safety of the safety' of the device is verified via tests." (Note 7 - this implies the subject device meets or exceeds the standards referenced by predicates, further supporting SE).

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states: "Clinical performance is not deemed necessary." (Section 7. Summary for clinical test). Therefore, there is no test set, sample size, or data provenance regarding clinical performance. The evaluation was based on bench testing and comparison to predicates.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
As no clinical test set was used, there were no experts establishing ground truth in a clinical context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no clinical test set was used, there was no adjudication method.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is a physical therapy device (compression therapy device), not an AI imaging or diagnostic algorithm. Thus, an MRMC study and AI assistance effectiveness are not applicable and were not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is a physical therapy device. The concept of "standalone algorithm performance" is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As no clinical studies were performed, there was no clinical ground truth established (such as expert consensus, pathology, or outcomes data). The "ground truth" for demonstrating substantial equivalence was adherence to recognized safety standards and functional comparison to legally marketed predicate devices.
The sample size for the training set:
As no machine learning or AI component is mentioned, there is no training set, and therefore no associated sample size.
How the ground truth for the training set was established:
As there is no training set for an AI/ML model, this question is not applicable.

Summary

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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.

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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)

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

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

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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 LONGESTSCIENCE&TECHNOLOGY CO.,LTD.	NormaTec Industries	Rapid Reboot Recovery Products,LLC	XIAMEN SENYANG CO., LTD.	--
510K number	TBD	K160608	K182668	K161907	--
Product Name	Compression Therapy DeviceLGT-2200SP	NormaTec Pulse and NormaTecPulse Pro	Rapid Reboot CompressionTherapy System	Pressure Therapy System, Pt1002	--
ClassificationName	Pow ered inflatable tubemassager	Pow ered inflatable tube massager	Pow ered inflatable tube massager	Pow ered inflatable tube massager	SE
RegulationClass	2	2	2	2	SE
RegulationNumber	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 forUse	Compression Therapy DeviceLGT-2200SP is intended for thetemporary relief of minor muscleaches and pains and for thetemporary increase in circulationto the treated areas, it cansimulate kneading and strokingof tissues by using an inflatablegarment.	The NormaTec Pulse and PulsePro is an air pressure massagerintended to temporarily relieveminor muscle aches and/or pains,and to temporarily increasecirculation to the treated areas.	The Rapid Reboot CompressionTherapy System is intended forthe temporary relief of minormuscle aches and pains and forthe temporary increase incirculation to the treated areas inpeople who are in good health.The Rapid Reboot CompressionTherapy System simulateskneading and stroking of tissues	The device is indicated for use bymedical professionals and patientat home, who are under medicalsupervision, in treating manyconditions, such as: Primarylymphedema, edema follow ingtrauma and sport injuries, postimmobilization edema, venousinsufficiencies, lymphedema.	MinordifferentNote 1
Elements ofcomparison	Subject Device	Predicate Device(Primary)	Predicate Device(II)	Predicate Device(III)	Verdict
			by using an inflatable garment.
		Device design
Power Source	AC100-240V, 50/60HzBattery 11.1V, 6500mAh meetIEC 62133	12 VDC via an IEC 60601-1compliant pow er supply (100-240VAC input)Optional Integrated rechargeablebattery	110 V, 60Hz	110 V, 60Hz	MinordifferenttNote 2
Powerconsumption	90VA	14W	30W	30W	MinordifferenttNote 2
Dimensions(WHD)	270148129mm	4"5" 9"	10" x 6.5" x 5"	260170130mm	MinordifferenttNote 2
Elements ofcomparison	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)	MinordifferentNote 2
Weight	2.0 Kg(4.4pounds)	3.6 pounds	5.8 pounds	5.8 pounds	MinordifferentNote 2
HousingMaterials	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:90X30cmLarge Leg Cuff:110X30cm	Minordifferent
Elements ofcomparison	Subject Device	Predicate Device(Primary)	Predicate Device(II)	Predicate Device(III)	Verdict
	4-chamber Leg Sleeve:S: $94.235.85$ cmM: $106.239.0$ cmL: $116.0*44.8$ cmImage: 4-chamber Leg Sleeve	Image: Normatec Arm Sleeve	Long: 14" x 48"X-Long: 14" x 52"Image: Rapid Reboot Leg Sleeve	Image: Blue Sleeve	Note 3
	4-chamber Waist, Hip and ThighSleeve: $71.3*71.8$ cmImage: 4-chamber Waist, Hip and Thigh Sleeve	Hip:Image: Normatec Hip Sleeve	Hip:Regular: 26" x 32"Large: 26" 35"Image: Rapid Reboot Hip Sleeve
	4-chamber Calf and FootSleeve: $61.0*30.1$ cmImage: 4-chamber Calf and Foot Sleeve		Arm:Regular: 18" x 38"Long: 18" x 44"Image: Rapid Reboot Arm Sleeve
Elements of		Predicate Device	Predicate Device	Predicate Device
comparison	Subject Device	(Primary)	(II)	(III)	Verdict
	Image: Subject Device		Image: Predicate Device (II)
Number ofChambers	4-chamber	5 or less	4 Chambers	4 Chambers for each unit	SE
SleeveMaterials	Polyether Nylon Fabric	200 denier nylon with apolyurethane laminate/extrusion	Nylon with a Polyurethanelaminate	Thermoplastic Urethane	MinordifferentNote 3
Mode ofCompression	Sequential	Sequential	Sequential	Sequential	SE
DevicePressurerange	30-150mmHg	30-110 mmHg	0-200 mmHg	0-250mmHg	MinordifferentNote 4
Elements ofcomparison	Subject Device	Predicate Device(Primary)	Predicate Device(II)	Predicate Device(III)	Verdict
TreatmentTime	1min-99min, default as 30min,step of 5min	Stays on until the user turns it offor can be set up to turn off in arange of 10mins to continuous	User determines therapy time.Choose from 10, 20, or 30 minutesession time, with option to addadditional 10 minutes to anytherapy time.	0 - 30mins	MinordifferenttNote 5
Work Mode	Image: Numbered boxes 1-4SEQUENTIAL: ①→②→③→④SQUEEZE: ①②→③④FLUSH: ①→①②→①②③→①②③④FLOW: ④→③→②→①RELEASE: ③④→①②WAVE: SEQUENTIAL+SEQUENTIAL+FLOW	SequentialImage: Diagram of NormaTec PulseImage: Diagram of Zone pulses	Model AImage: Model AModel BImage: Model B	Model AImage: Model AModel BImage: Model B	MinordifferenttNote 6
Elements ofcomparison	Subject Device	Predicate Device(Primary)	Predicate Device(II)	Predicate Device(III)	Verdict
Patient contact	Non-conductive appliances	Non-conductive appliances	Image: Predicate Device II	Image: Predicate Device III	SE
Software/Firmware/Microprocessor Control	Microprocessor	Microprocessor	Microprocessor	Microprocessor	SE
Technology	Compressor and valvesystem w hich sequentiallyinflates cells of appliance	Compressor and valve systemw hich sequentially inflates cells ofappliance	Compressor and valvesystem w hich sequentiallyinflates cells of appliance	Compressor and valvesystem w hich sequentiallyinflates cells of appliance	SE
FDA-Recognized Standards
Electricalsafety, EMC	ANSI/AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 62133ISO 10993-5ISO 10993-10	ES 60601-1IEC 60601-1-2;IEC 60601-1-11	IEC 60601-1:2014;IEC 60601-1-2:2014;EN ISO 10993-5:2009EN ISO 10993-10:2010	IEC 60601-1IEC 60601-1-2ISO10993-5ISO10993-10	MinordifferenttNote 7

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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.

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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

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).