Compression Therapy Device Model LGT-2200SP

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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. {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 {2}------------------------------------------------ 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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EF PSC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ ## 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 {4}------------------------------------------------ Regulation Class: 2 - 3. 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. {6}------------------------------------------------ | Elements of | | Predicate Device | Predicate Device | Predicate Device | | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | comparison | Subject Device | (Primary) | (II) | (III) | Verdict | | Manufacturer | GUANGZHOU LONGEST<br>SCIENCE&TECHNOLOGY CO.,<br>LTD. | NormaTec Industries | Rapid Reboot Recovery Products,<br>LLC | XIAMEN SENYANG CO., LTD. | -- | | 510K number | TBD | K160608 | K182668 | K161907 | -- | | Product Name | Compression Therapy Device<br>LGT-2200SP | NormaTec Pulse and NormaTec<br>Pulse Pro | Rapid Reboot Compression<br>Therapy System | Pressure Therapy System, Pt<br>1002 | -- | | Classification<br>Name | Pow ered inflatable tube<br>massager | Pow ered inflatable tube massager | Pow ered inflatable tube massager | Pow ered inflatable tube massager | SE | | Regulation<br>Class | 2 | 2 | 2 | 2 | SE | | Regulation<br>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<br>Use | Compression Therapy Device<br>LGT-2200SP is intended for the<br>temporary relief of minor muscle<br>aches and pains and for the<br>temporary increase in circulation<br>to the treated areas, it can<br>simulate kneading and stroking<br>of tissues by using an inflatable<br>garment. | The NormaTec Pulse and Pulse<br>Pro is an air pressure massager<br>intended to temporarily relieve<br>minor muscle aches and/or pains,<br>and to temporarily increase<br>circulation to the treated areas. | The Rapid Reboot Compression<br>Therapy System is intended for<br>the temporary relief of minor<br>muscle aches and pains and for<br>the temporary increase in<br>circulation to the treated areas in<br>people who are in good health.<br>The Rapid Reboot Compression<br>Therapy System simulates<br>kneading and stroking of tissues | The device is indicated for use by<br>medical professionals and patient<br>at home, who are under medical<br>supervision, in treating many<br>conditions, such as: Primary<br>lymphedema, edema follow ing<br>trauma and sport injuries, post<br>immobilization edema, venous<br>insufficiencies, lymphedema. | Minor<br>differen<br>t<br>Note 1 | | Elements of<br>comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(II) | Predicate Device<br>(III) | Verdict | | | | | by using an inflatable garment. | | | | | | Device design | | | | | Power Source | AC100-240V, 50/60Hz<br>Battery 11.1V, 6500mAh meet<br>IEC 62133 | 12 VDC via an IEC 60601-1<br>compliant pow er supply (100-240<br>VAC input)<br>Optional Integrated rechargeable<br>battery | 110 V, 60Hz | 110 V, 60Hz | Minor<br>different<br>t<br>Note 2 | | Power<br>consumption | 90VA | 14W | 30W | 30W | Minor<br>different<br>t<br>Note 2 | | Dimensions<br>(W*H*D) | 270*148*129mm | 4"*5" *9" | 10" x 6.5" x 5" | 260*170*130mm | Minor<br>different<br>t<br>Note 2 | | Elements of<br>comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(II) | Predicate Device<br>(III) | Verdict | | Photo | Image: Subject Device | Image: Predicate Device (Primary) | Image: Predicate Device (II) | Image: Predicate Device (III) | Minor<br>different<br>Note 2 | | Weight | 2.0 Kg(4.4pounds) | 3.6 pounds | 5.8 pounds | 5.8 pounds | Minor<br>different<br>Note 2 | | Housing<br>Materials | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | SE | | Sleeves | 4-chamber Arm Sleeve:<br>97.0*28.7 cm | Leg: | Leg:<br>X-Short: 14" x 41"<br>Short: 14" x 43"<br>Medium: 14" x 45" | Small Leg Cuff:90X30cm<br>Large Leg Cuff:110X30cm | Minor<br>different | | Elements of<br>comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(II) | Predicate Device<br>(III) | Verdict | | | 4-chamber Leg Sleeve:<br>S: $94.2*35.85$ cm<br>M: $106.2*39.0$ cm<br>L: $116.0*44.8$ cm<br><br>Image: 4-chamber Leg Sleeve | Image: Normatec Arm Sleeve | Long: 14" x 48"<br>X-Long: 14" x 52"<br><br>Image: Rapid Reboot Leg Sleeve | Image: Blue Sleeve | Note 3 | | | 4-chamber Waist, Hip and Thigh<br>Sleeve: $71.3*71.8$ cm<br><br>Image: 4-chamber Waist, Hip and Thigh Sleeve | Hip:<br><br>Image: Normatec Hip Sleeve | Hip:<br>Regular: 26" x 32"<br>Large: 26" 35"<br><br>Image: Rapid Reboot Hip Sleeve | | | | | 4-chamber Calf and Foot<br>Sleeve: $61.0*30.1$ cm<br><br>Image: 4-chamber Calf and Foot Sleeve | | Arm:<br>Regular: 18" x 38"<br>Long: 18" x 44"<br><br>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 of<br>Chambers | 4-chamber | 5 or less | 4 Chambers | 4 Chambers for each unit | SE | | Sleeve<br>Materials | Polyether Nylon Fabric | 200 denier nylon with a<br>polyurethane laminate/extrusion | Nylon with a Polyurethane<br>laminate | Thermoplastic Urethane | Minor<br>different<br>Note 3 | | Mode of<br>Compression | Sequential | Sequential | Sequential | Sequential | SE | | Device<br>Pressure<br>range | 30-150mmHg | 30-110 mmHg | 0-200 mmHg | 0-250mmHg | Minor<br>different<br>Note 4 | | Elements of<br>comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(II) | Predicate Device<br>(III) | Verdict | | Treatment<br>Time | 1min-99min, default as 30min,<br>step of 5min | Stays on until the user turns it off<br>or can be set up to turn off in a<br>range of 10mins to continuous | User determines therapy time.<br>Choose from 10, 20, or 30 minute<br>session time, with option to add<br>additional 10 minutes to any<br>therapy time. | 0 - 30mins | Minor<br>different<br>t<br>Note 5 | | Work Mode | Image: Numbered boxes 1-4<br><br>SEQUENTIAL: ①→②→③→④<br>SQUEEZE: ①②→③④<br>FLUSH: ①→①②→①②③→①<br>②③④<br>FLOW: ④→③→②→①<br>RELEASE: ③④→①②<br>WAVE: SEQUENTIAL+<br>SEQUENTIAL+FLOW | Sequential<br>Image: Diagram of NormaTec Pulse<br>Image: Diagram of Zone pulses | Model A<br>Image: Model A<br>Model B<br>Image: Model B | Model A<br>Image: Model A<br>Model B<br>Image: Model B | Minor<br>different<br>t<br>Note 6 | | Elements of<br>comparison | Subject Device | Predicate Device<br>(Primary) | Predicate Device<br>(II) | Predicate Device<br>(III) | Verdict | | Patient contact | Non-conductive appliances | Non-conductive appliances | Image: Predicate Device II | Image: Predicate Device III | SE | | Software/Firm<br>ware/Micropro<br>cessor Control | Microprocessor | Microprocessor | Microprocessor | Microprocessor | SE | | Technology | Compressor and valve<br>system w hich sequentially<br>inflates cells of appliance | Compressor and valve system<br>w hich sequentially inflates cells of<br>appliance | Compressor and valve<br>system w hich sequentially<br>inflates cells of appliance | Compressor and valve<br>system w hich sequentially<br>inflates cells of appliance | SE | | FDA-Recognized Standards | | | | | | | Electrical<br>safety, EMC | ANSI/AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 62133<br>ISO 10993-5<br>ISO 10993-10 | ES 60601-1<br>IEC 60601-1-2;<br>IEC 60601-1-11 | IEC 60601-1:2014;<br>IEC 60601-1-2:2014;<br>EN ISO 10993-5:2009<br>EN ISO 10993-10:2010 | IEC 60601-1<br>IEC 60601-1-2<br>ISO10993-5<br>ISO10993-10 | Minor<br>different<br>t<br>Note 7 | {7}------------------------------------------------ {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