Air compression therapy system FO3002

{0}------------------------------------------------ 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 Department of Health & Human Services logo. 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 23, 2021 Foshan Hongfeng Co., Ltd. % Sam Lin Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai, 201306 Cn Re: K212169 Trade/Device Name: Air compression therapy system FO3002 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: October 18, 2021 Received: October 18, 2021 Dear Sam Lin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ 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 medical devices and radiation-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 Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212169 Device Name Air compression therapy system FO3002 Indications for Use (Describe) Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | 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. 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}------------------------------------------------ ### K212169 Traditional May 31, 2021 ### Type of Submission ### Date Prepared #### Submission Sponsor Manufacturer Name Address Tel Email Contact Person ### Device Identification - Trade Name Regulation Number Regulation Name Device Classification Product Code Panel Previous Submissions ### Application Correspondent Company Name Address Tel Email Contact Person ### Indications for Use FOSHAN HONGFENG CO., LTD. No.4-2 Leqiang Road, Leping Sanshui, Foshan, Guangdong, China 86-0757-8392028 573619164@qq.com Dongfeng Cheng Air compression therapy system FO3002 21 CFR 890.5650 Power inflatable tube massager Class II IRP Physical Medicine None Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District, Shanghai, China 86-15626132181 sam(@spicagloble.com Sam Lin Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. ### Device Descrintion Air compression therapy system FO3002 is consist of air pressure sensor, air pump, sleeves etc {4}------------------------------------------------ working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Air compression therapy system FO3002, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas. Clothing should be worn between the device and the patient's skin. ### Predicate and Reference Device Information | Sponsor | NormaTec Industries, LP | |-------------------|---------------------------------------| | Trade/Device Name | NormaTec Pulse and NormaTec Pulse Pro | | 510(K) number | K160608 | | Regulation Number | 21 CFR 890.5650 | ### Performance Testing - Clinical Not Applicable. ### Performance Testing - Animal Not Applicable. {5}------------------------------------------------ | | Subject Device | Predicate Device | Differences Discussion | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Device name | Air compression therapy system FO3002 | NormaTec Pulse and NormaTec Pulse Pro | N/A | | 510(k) number | K212169 | K160608 | N/A | | Manufacturer | FOSHAN HONGFENG CO., LTD. | NormaTec Industries, LP | N/A | | Product regulation | 21 CFR 890.5650 | 21 CFR 890.5650 | Same | | Classification name | Massager, Powered Inflatable Tube | Massager, Powered Inflatable Tube | Same | | Regulation class | 2 | 2 | Same | | Product code | IRP | IRP | Same | | Indications for use | Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | 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. | Same | | Rx or OTC | OTC | OTC | Same | | Pressure range | 30-110mmHg | 30-110mmHg | Same | | Treatment time | 10-60min | Stays on until the user turns it off or can be set up to turn off in a range of 10 mins to | Similar<br>The treatment time of subject device is smaller than predicate | | | | continuous / User controlled 10 minutes to 175 minutes or continuous -total time over 4 segments. | device (K160608), so the difference of treatment time would not raise adversely impact on safety and effectiveness. | | Standard | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-2, IEC 60601-1-11 , IEC 62133-2, ISO 10993-5, ISO 10993-10 | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Similar | | Mode of compression | Sequential | Sequential Gradient, Peristaltic and Pulsing | Same | | Power source | Adaptor: AC 100-240V, 50/60Hz<br>Main unit: DC 15V, 1.5A | 12 VDC via an IEC 60601-1 compliant power supply (100-240 VAC input) Optional Integrated rechargeable battery | Similar | | Power consumption | 22.5VA | 14W | Similar | | Dimensions (W*H*D) | 265 x 130 x 100mm | 4" x 5" x 9" | Similar | | Photo | Image: a white remote control with several buttons | N/A | N/A | | Size and appearance of sleeves (leg part) | Image: a black leg sleeve | Short: 14" x 43"<br>Standard: 14" x 48"<br>Tall: 14" x 60" | Similar | # Table 6A: Summary of Comparison {6}------------------------------------------------ {7}------------------------------------------------ | | 510(K) Summary | |--|----------------| |--|----------------| | | XL: 110 x 70cm<br>XXXL: 125 x 76cm | | | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Housing<br>materials | Molded ABS enclosure | Molded ABS enclosure | Same | | Number of<br>chambers | 6 | 5 or less | Similar | | | A Normal Mode: Chamber ① inflates to pressure set value within<br>maximum 12 seconds. If the chamber pressure reaches preset<br>value within 12 seconds, holding pressure on for the rest of the<br>period then shift to next chamber inflating. If the chamber<br>pressure doesn't reach pressure preset value within the first 12<br>seconds, inflation is extended for additional maximum 10<br>seconds. Within this 10-second period, if the chamber pressure<br>reaches the preset value, then shift to next chamber inflating. If<br>the chamber pressure cannot reach the preset value at the end of<br>additional 10 seconds, then shift to next chamber inflating<br>automatically. 3 seconds after the next chamber (for example<br>Chamber ②) inflating, the inflated chamber (for example<br>Chamber ①) deflates. Chamber ② works like Chamber ①.<br>Chamber ③, ④, ⑤, ⑥ repeats the similar procedure as Chamber<br>②, ③, ④, ⑤.<br>B Sequential Mode: Chamber ① inflates to pressure set value<br>within maximum 12 seconds. If the chamber pressure reaches<br>preset value within the 12 seconds, holding pressure on them shift<br>to next chamber inflating. If the chamber pressure doesn't reach<br>pressure preset value within the first 12 seconds, inflation is<br>extended for additional maximum 10 seconds. Within this | Sequential mode:<br>Starting with the distal chamber<br>and progressing up the proximal<br>chamber, each section<br>compresses and the pressure<br>gradually rises to the<br>pre-determined air pressure<br>level, then decompresses and<br>the air pressure drops.<br>Once the top section<br>decompresses, the cycle begins<br>again. again.<br>Normatec Pulse mode:<br>Starting with the distal zone and<br>progressing up the proximal<br>zone, one zone compresses and<br>the pressure gradually rises to<br>the pre-determined air pressure<br>level, holds the air of previous<br>two zone, the other zones do not<br>hold, until the last zone | Although the subject device<br>provides 5 kinds of work mode,<br>the Mode A and Mode C are the<br>same with predicate device<br>(K160608), while the other<br>work modes of subject device<br>just have difference about<br>inflatable order of the different<br>chambers. The treatment<br>pressure range are the same<br>under different work modes, so<br>the difference of pressure range<br>would not raise adversely<br>impact on safety and<br>effectiveness. | | Work mode | | | | {8}------------------------------------------------ | 10-second period, if the chamber pressure reaches the preset<br>value, holding pressure on then shift to next chamber inflating. If<br>the chamber pressure cannot reach the preset value at the end of<br>additional 10 seconds, holding pressure on then shift to next<br>chamber inflating automatically. Chamber ② works like Chamber<br>①. Chamber ③, ④, ⑤, ⑥ repeats the similar procedure as<br>Chamber 2, 3, 4 ⑤. After the last Chamber ⑥ completed<br>inflation, Chamber ①, ②, ③, ④, ⑤, ⑥ operation cycle starts 13<br>seconds after deflation begins. | finished, deflate the all last<br>three zone then enter into next<br>cycle. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | C Double Mode: Chamber ① ② as a group inflates<br>synchronously to pressure set value within maximum 24 seconds.<br>If the grouped chamber pressure reaches preset value within the<br>24 seconds, holding pressure on for the rest of the period then<br>shift to next group (③ ④) inflating. If the grouped chamber<br>pressure doesn't reach pressure preset value within the first 24<br>seconds, inflation is extended for additional maximum 20<br>seconds. Within this 20-second period, if the Chamber ① ②<br>pressure reaches the preset value, then shift to next group (34)<br>inflating. If the Chamber ① ② pressure cannot reach the preset<br>value at the end of additional 20 seconds, then shift to next group<br>(34) inflating automatically. 3 seconds after the next group<br>(Chamber ③ ④) inflating, the inflated group (Chamber ① ②<br>deflates. Chamber group ③ ④⑤⑥ works like Group ① ②.<br>Start next Chamber (① ②)-(③ ④)-(⑤ ⑥) operation cycle 13<br>seconds after Chamber group ⑤ ⑥ begins deflation. | | | D Whole Mode: Chamber 1, 2, 3, 4, 5, 6 inflates<br>synchronously to pressure set value within maximum 72 seconds. | | {9}------------------------------------------------ | | If the chamber pressure reaches preset value within the 72<br>seconds, holding pressure on for the rest of the period, then<br>deflates synchronously. If the chamber pressure doesn't reach<br>pressure preset value within the first 72 seconds, inflation is<br>extended for additional maximum 36 seconds. Within this 36-<br>second period, if the chamber pressure reaches the preset value,<br>then deflates synchronously. If the chamber pressure cannot<br>reaches the preset value at the end of additional 36 seconds, then<br>Chamber (1), (2), (3), (4), (5), (6) deflates automatically. Repeat the<br>Chamber (1), (2), (3), (4), (5), (6) operation cycle 13 seconds after<br>Chamber (1), (2), (3), (4), (5), (6) deflation begins.<br>E Combined A mode + B mode: Normal Mode followed by<br>Sequential Mode<br>Image: Modes of operation | | | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------| | | | | | | Safety feature | Button on display allows user to stop or pause therapy session at<br>any time | Button on display allows user to<br>stop or pause therapy session at<br>any time | Same | | Technology | Compressor and valve system which sequentially inflates<br>inflatable chambers | Compressor and valve system which sequentially inflates | Same | | | | inflatable chambers | | {10}------------------------------------------------ ### Performance Characteristic The device meets all the applicable technical requirements of : IEC 60601-1-11: 2015 - Medical electrical equipments for Basic Safety and Essential Performance - Collateral Standard: Requirements for medical equipment and medical electrical systems used in the home healthcare environment IEC 60601-1-2: 2014 - Medical electrical equipments for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility ANSI AAM ES60601-1:2005/(R)2012 and A1:2012, C1:2009/R)2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ISO 10993-5: 2009 - Biological Evaluation of Medical Device - Part 5: Tests for in vitro Cytotoxicity ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization IEC 62133-2: 2017 - Secondary cells and batteries containing alkaline or other nor-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems ### Conclusion Based on the indications for use, technological characteristical performance data, "Air compression therapy system FO3002 (K number)" is as safe, as effective, and performs as well as the legally market predicate devices, "NormaTec Pulse Pro (K160608)". Therefore, the subject device is substantially equivalent to the predicate device.