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.

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 in 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).

AI/ML Overview

The provided text is a 510(k) summary for the ProPerformance Recovery System, a powered inflatable tube massager. This device is seeking clearance based on substantial equivalence to a predicate device.

The context of this document is a regulatory submission for a medical device that does not involve an AI/ML algorithm. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI/ML device meets acceptance criteria are not applicable in this case. The device is a physical product, and its performance is assessed through bench testing and comparison to a legally marketed predicate, not through evaluation of an AI's diagnostic or predictive capabilities.

Here's an analysis based on the provided document, addressing the relevant points and explicitly stating N/A for those that are not applicable to this type of device:

Analysis of ProPerformance Recovery System Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" in the sense of accuracy metrics for an algorithm. Instead, it demonstrates performance by showing equivalence to a predicate device and compliance with recognized voluntary standards through bench testing.

Acceptance Criterion (Implicit)	Reported Device Performance
Indications for Use:	Identical to predicate: Temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas in good health, simulating kneading and stroking of tissues using an inflatable garment.
Classification:	Identical to predicate: Class II Device, IRP (21 CFR 890.5650).
OTC or Prescription Use:	Identical to predicate: Over-The-Counter (OTC).
Environment of Use:	Identical to predicate: Clinics, hospital, athlete training, and home environments.
Compliance with Voluntary Standards:	Meets and exceeds predicate's compliance: AAMI ANSI ES60601-1 (replaced IEC 60601-1), IEC 60601-1-2 (Electromagnetic Disturbances), and additionally IEC 60601-1-11 (Home Healthcare Environment) which the predicate did not explicitly declare. Bench testing was performed to confirm compliance with these standards (Sections 16, 17, and 18 for test reports).
Mode of Operation:	Identical to predicate: Sequential/Peristaltic, with "A" and "B" modes as described.
Power:	Equivalent to predicate: 110-125Vac 60Hz. Predicate is 110V, 60Hz.
Device Pressure Range:	Identical to predicate: 20-200 mmHg.
Treatment Time:	Identical to predicate: User-determined, choices of 10, 20, or 30 minutes, with option to add 10 minutes.
Garment Contact Surface Material:	Identical to predicate: Nylon with a Polyurethane laminate. Identical to reference device K181409.
Attachments (Leg, Arm, Hip):	Identical in size and construction to predicate (Yes for all).
Number of Inflatable Appliance Segments:	Identical to predicate: 4.
Weight:	Similar to predicate: 5.7 pounds (new device) vs. 5.8 pounds (predicate).
Dimensions (W x H x D):	Similar to predicate: 11.25" x 5.1" x 6.7" (new device) vs. 10" x 6.5" x 5" (predicate).
Housing Materials and Constructions:	Identical to predicate: Molded ABS enclosure.
Patient Contact:	Identical to predicate: Non-conductive appliances.
Safety Features:	Identical to predicate: Button on display allows user to stop or pause therapy session at any time.
Functionality (Controls, Indicators, Performance testing):	Tested to ensure all requirements met. Verified through internal testing (Sections 16, 18). This includes confirmation of basic operational functionality in line with stated design.
No New Safety/Efficacy Concerns:	No differences between the proposed device and the predicate device that raise new safety and efficacy concerns. This is a core conclusion for 510(k) substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: Not applicable in the context of an AI/ML test set. The performance evaluation for this physical device relies on bench testing for compliance with electrical safety, EMC, and home use standards, and on direct comparison of specifications and features to a predicate device. The document mentions "Testing of all controls," "Testing of all indicators," and "Testing of performance" without specifying a sample size for these physical tests, which are typically product-level validations.
Data Provenance: The data comes from internal "bench" performance testing conducted by the manufacturer/applicant to demonstrate compliance with voluntary standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11). It is retrospective in the sense that the test results are submitted after completion. The country of origin of the data is implicitly the country where the testing was performed, likely related to the applicant's location (Menlo Park, CA) or their manufacturing partner (Xiamen Senyang Co., Ltd., China, for the identical hardware/software model).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. This pertains to AI/ML ground truth establishment. For a physical device, "ground truth" is typically defined by engineering specifications, regulatory standards, and physical measurements. The "experts" involved are likely engineers, quality assurance personnel, and regulatory professionals.

4. Adjudication Method for the Test Set:

Not applicable. This applies to multi-reader evaluations in AI/ML studies. Performance validation here involves meeting predefined engineering and regulatory specifications through testing.

5. 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:

No. This is not an AI-assisted device. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This device is a physical product, not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used:

For this device, the "ground truth" is based on:
- Engineering Specifications: The device's design and operational parameters (e.g., pressure range, modes, dimensions).
- Regulatory Standards: Compliance with recognized international and national consensus standards for medical electrical equipment (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11).
- Predicate Device Equivalence: The specifications and performance of the legally marketed predicate device (K182668 - Rapid Reboot Compression Therapy System) and a reference device (K181409 - Pressure Therapy System PT1003).

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no AI/ML training set, this question is irrelevant.

In summary, the ProPerformance Recovery System is a conventional medical device. Its "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant safety and performance standards through bench testing, rather than through clinical studies or AI/ML performance evaluations.

Summary

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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.

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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 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

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Indications for Use

510(k) Number (if known) K192252

Device Name ProPerformance Recovery System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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
		Page 1 of 7
Date Prepared:	15 Aug 2019
Applicant	Menlo Brands LLC2045 Avy AvenueMenlo Park, CA 94025Tel – 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 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).

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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

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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 (21CFR890.5650)	Class II Device, IRP (21CFR890.5650)	Identical
Indications for use	The Speed Hound ProPerformanceRecovery System is indicated for thetemporary relief of minor muscleaches and pains and for temporaryincrease in circulation to the treatedareas in people who are in goodhealth. The Speed Hound RecoverySystem simulates kneading andstroking of tissues by using aninflatable garment	The Rapid Reboot CompressionTherapy System is intended for thetemporary relief of minor muscle achesand pains and for the temporaryincrease in circulation to the treatedareas in people who are ingood health.The Rapid Reboot CompressionTherapy System simulates kneading andstroking oftissues by using an inflatable garment.	Identical
OTC or Prescription	OTC	OTC	Identical
Environment of Use	Clinics, hospital, athletetraining, and homeenvironments	Clinics, hospital, athletetraining, and homeenvironments	Identical
Compliance with Voluntary standards	ES 60601-1, IEC 60601-1-2, IEC60601-1-11	IEC 60601-1, IEC 60601-1-2	ProPerformance RecoverSystem meets home usestandard
Mode of Operation	Sequential/Peristaltic	Sequential/Peristaltic	Identical
Power	110-125Vac 60Hz	110 V, 60Hz	Equivalent
DevicePressure range	20-200 mmHg	20 - 200 mmHg	Identical
Treatment Time	User determines therapytime. Choose from 10, 20,or 30 minute session time,with option to addadditional 10 minutes toany therapy time.	User determines therapytime. Choose from 10, 20,or 30 minute session time,with option to addadditional 10 minutes toany 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

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Speed Hound

510(k) SummaryPage 4 of 7
material	laminate	laminate	device as below
Leg Attachment	Yes	Yes	Identical in size andconstruction
Arm Attachment	Yes	Yes	Identical in size andconstruction
HipAttachment	Yes	Yes	Identical in size andconstruction
Number of Inflatable appliancesegments	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 allowsuser to stop or pausetherapy session at any time.	Button on display allowsuser to stop or pausetherapy session at any time.	Identical
Modes	2 Modes: "A" mode inflates anddeflates chambers from bottom to up(distal to proximal chambers), one ata time"B" mode also inflates from bottomup, but maintains pressure in lowerchambers as it works it way to thetop. Then all chambers releasepressure at the same time once allchambers have sequentially inflated	2 Modes: "A" mode inflates anddeflates chambers from bottom to up(distal to proximal chambers), one at atime"B" mode also inflates from bottom up,but maintains pressure in lowerchambers as it works it way to the top.Then all chambers release pressure atthe same time once all chambers havesequentially inflated	Identical

510(k) Summary

Reference Device: Pressure Therapy System PT1003 - 510(k) K181409

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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.

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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.

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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.

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).