ProPerformance Recovery System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 19, 2019 Menlo Brands LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive Suite 510k Saint Paul, Minnesota 55114 Re: K192252 Trade/Device Name: ProPerformance Recovery System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: August 19, 2019 Received: August 20, 2019 Dear Prithul Bom: 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 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 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192252 #### Device Name ProPerformance Recovery System #### Indications for Use (Describe) The Speed Hound ProPerformance Recovery System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Speed Hound Recovery System simulates 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. 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}------------------------------------------------ | | 510(k) Summary | | | |----------------------------|-----------------------------------------------------------------------------------|-------------|--| | | | Page 1 of 7 | | | Date Prepared: | 15 Aug 2019 | | | | Applicant | Menlo Brands LLC<br>2045 Avy Avenue<br>Menlo Park, CA 94025<br>Tel – 650 796 8905 | | | | Official Contact: | Sam Chi, CEO | | | | Proprietary or Trade Name: | ProPerformance Recovery System | | | | Common/Usual Name: | Powered Inflatable Tube Massager | | | | Classification Name: | IRP - Massager Powered Inflatable Tube (CFR 890.5650 | | | | Predicate Devices: | K182668 – Rapid Reboot Compression Therapy System | | | ### Device Description: This submission is for the Speed Hound ProPerformance Recovery System. The Speed Hound ProPerformance Recovery System is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The device is a Class II, type BF applied part that receives power through a non-detachable power cord The ProPerformance Recovery System consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment A description of each of these components is provided below. The hardware and software of this device is identical to the model PT1003 by Xiamen Senyang Co., Ltd., cleared under 510(k) K181409 The "garments" (leg, arm and hip) and the plastic air tubing are of identical materials to the components of the FDA-cleared PT1003 (K181409). {4}------------------------------------------------ ## 510(k) Summary Page 2 of 7 #### Indications for Use: The Speed Hound ProPerformance Recovery System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Speed Hound Recovery System simulates kneading and stroking of tissues by using an inflatable garment. #### Patient Population: Adults #### Environments of Use: Clinics, hospital, athlete training, and home environments {5}------------------------------------------------ #### 510(k) Summary Page 3 of 7 | Model Name | New Device | Predicate Device | Comment | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | 510(k) Number | ProPerformance Recovery System | Rapid Reboot | | | | 510(k) TBD | 510(K) K182668 | | | Classification | Class II Device, IRP (21<br>CFR890.5650) | Class II Device, IRP (21<br>CFR890.5650) | Identical | | Indications for use | The Speed Hound ProPerformance<br>Recovery System is indicated for the<br>temporary relief of minor muscle<br>aches and pains and for temporary<br>increase in circulation to the treated<br>areas in people who are in good<br>health. The Speed Hound Recovery<br>System simulates kneading and<br>stroking of tissues by using an<br>inflatable garment | The Rapid Reboot Compression<br>Therapy System is intended for the<br>temporary relief of minor muscle aches<br>and pains and for the temporary<br>increase in circulation to the treated<br>areas in people who are ingood health.<br>The Rapid Reboot Compression<br>Therapy System simulates kneading and<br>stroking of<br>tissues by using an inflatable garment. | Identical | | OTC or Prescription | OTC | OTC | Identical | | Environment of Use | Clinics, hospital, athlete<br>training, and home<br>environments | Clinics, hospital, athlete<br>training, and home<br>environments | Identical | | Compliance with Voluntary standards | ES 60601-1, IEC 60601-1-2, IEC<br>60601-1-11 | IEC 60601-1, IEC 60601-1-2 | ProPerformance Recover<br>System meets home use<br>standard | | Mode of Operation | Sequential/Peristaltic | Sequential/Peristaltic | Identical | | Power | 110-125Vac 60Hz | 110 V, 60Hz | Equivalent | | Device<br>Pressure range | 20-200 mmHg | 20 - 200 mmHg | Identical | | Treatment Time | User determines therapy<br>time. Choose from 10, 20,<br>or 30 minute session time,<br>with option to add<br>additional 10 minutes to<br>any therapy time. | User determines therapy<br>time. Choose from 10, 20,<br>or 30 minute session time,<br>with option to add<br>additional 10 minutes to<br>any therapy time. | Identical | | Garments contact surface | Nylon with a Polyurethane | Nylon with a Polyurethane | Identical to reference | ## Table 5.1 - Table of the Similarities and Differences of Predicate vs. Proposed Device {6}------------------------------------------------ Speed Hound | 510(k) Summary<br>Page 4 of 7 | | | | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------| | material | laminate | laminate | device as below | | Leg Attachment | Yes | Yes | Identical in size and<br>construction | | Arm Attachment | Yes | Yes | Identical in size and<br>construction | | HipAttachment | Yes | Yes | Identical in size and<br>construction | | Number of Inflatable appliance<br>segments | 4 | 4 | Identical | | Weight | 5.7 pounds | 5.8 pounds | Similar | | Dimensions (W x H x D) | 11.25" x 5.1" x 6.7" | 10" x 6.5" x 5" | Similar | | Housing Materials and Constructions | Molded ABS enclosure | Molded ABS enclosure | Identical | | Patient contact | Non-conductive appliances | Non-conductive appliances | Identical | | Safety Features | Button on display allows<br>user to stop or pause<br>therapy session at any time. | Button on display allows<br>user to stop or pause<br>therapy session at any time. | Identical | | Modes | 2 Modes: "A" mode inflates and<br>deflates chambers from bottom to up<br>(distal to proximal chambers), one at<br>a time<br>"B" mode also inflates from bottom<br>up, but maintains pressure in lower<br>chambers as it works it way to the<br>top. Then all chambers release<br>pressure at the same time once all<br>chambers have sequentially inflated | 2 Modes: "A" mode inflates and<br>deflates chambers from bottom to up<br>(distal to proximal chambers), one at a<br>time<br>"B" mode also inflates from bottom up,<br>but maintains pressure in lower<br>chambers as it works it way to the top.<br>Then all chambers release pressure at<br>the same time once all chambers have<br>sequentially inflated | Identical | 510(k) Summary Reference Device: Pressure Therapy System PT1003 - 510(k) K181409 {7}------------------------------------------------ #### 510(k) Summary Page 5 of 7 ### Substantial Equivalence Discussion In the above detailed table we have compared the ProPerformance Recovery System to the predicate for equivalence of: #### Indications - The Speed Hound ProPerformance Recovery System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Speed Hound Recovery System simulates kneading and stroking of tissues by using an inflatable garment. These indications are identical to the predicate. Prescriptive - The ProPerformance Recovery System is OTC as is the predicate Design, Technology and Principle of Operation - The ProPerformance Recovery System have equivalent design and features when compared to the predicate and have identical technology to the predicate Performance and Specifications – The ProPerformance Recovery System have equivalent specifications of performance when compared to the predicate. Compliance with standards - The predicate devices declares compliance with IEC 60601-1 and IEC 60601-1-2. The ProPerformance Recovery System complies with AAMI ANSI ES6060-1 (which replaced IEC 60601-1), IEC 60601-1-11 for home use and IEC 60601-1-2. ### Materials - The patient contacting materials of the ProPerformance Recovery System are the inflatable garments which are identical to the reference device Pressure Therapy System PT1003 - 510(k) K181409. ### Patient Population - The ProPerformance Recovery System and predicates are indicated for adults ## Environment of Use - The ProPerformance Recovery System and predicates are for use in clinics, hospital, athlete training, and home environments. #### Differences - There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns. {8}------------------------------------------------ ### 510(k) Summary Page 6 of 7 # Performance Testing ## Bench: The device has been tested to insure that it all requirements have been met, this includes: - Testing of all controls . - Testing of all indicators . - Testing of performance ● See Sections 16 and 18 for test reports for the above. The device has also been tested to the requirements of the following standards: - . AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: general requirements for basic safety and essential performance - IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances -. Requirements and Tests - . IEC 60601-1-11: 2015, Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment See Section 17 for test reports for the above. ## Animal: No animal testing was performed ## Clinical: No clinical testing was performed ## Differences - There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns. #### 12.2 Substantial Equivalence Rationale The ProPerformance Recovery System is viewed as substantially equivalent to the predicate device because: Indications - are identical to the predicate Prescriptive - The ProPerformance Recovery System and predicate are OTC. {9}------------------------------------------------ #### 510(k) Summary Page 7 of 7 Design, Technology and Principle of Operation - The ProPerformance Recovery System has equivalent design and features when compared to the predicate and have the identical technology to the predicate. Performance and Specifications - The ProPerformance Recovery System has equivalent specifications of performance when compared to the predicate. Compliance with standards – The predicate device is compliant with IEC 60601-1 and IEC 60601-1-2. The ProPerformance Recovery System complies with AAMI ANSI ES6060-1 (which replaced IEC 60601-1) and IEC 60601-1-2. Additionally the ProPerformance Recovery System complies with IEC 60601-1-11 for home healthcare. Materials - The patient contacting materials of the ProPerformance Recovery System are the inflatable appliances they are identical to the predicate. Environment of Use - Clinics, hospital, athlete training, and home environments s, not specified for predicate but predicate is OTC. Features - The ProPerformance Recovery System has equivalent features when compared to the predicate. ## Conclusion The ProPerformance Recovery System ise substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness.