IAF-SYSTEM is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. IAF-SYSTEM simulates kneading of tissues by using an inflatable garment.

Device Description

Subject device consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has four (4) compression chambers. 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. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body

AI/ML Overview

The provided text describes a 510(k) premarket notification for the IAF-SYSTEM, a powered inflatable tube massager. It details the device's characteristics and compares them to a predicate device (Rapid Reboot Compression Therapy System, K182668) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the traditional sense of a clinical trial or performance study comparing a specific metric against a predefined threshold. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing various technological characteristics and safety standards.

The acceptance criteria are implicitly derived from the similarity to the predicate device and compliance with relevant safety standards. The "reported device performance" is essentially the detailed description of the subject device's features and its conformity to the standards.

While not a direct "acceptance criteria" table, the provided comparison table in the 510(k) summary (pages 5-8) serves as the basis for demonstrating equivalence. Key comparisons include:

Characteristic	Predicate Device Performance (Rapid Reboot Compression Therapy System)	Subject Device Performance (IAF-SYSTEM)	Comparison / Acceptance
Indications for Use (IFU)	Temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas in people in good health; simulates kneading and stroking of tissues using inflatable garment.	Temporary relief of minor muscle aches and pains and temporary increase in circulation to treated areas in people in good health; simulates kneading and stroking of tissues using inflatable garment.	Same. This is a critical acceptance criterion for substantial equivalence.
Classification	Class II Device, IRP (21 CFR 890.5650)	Class II Device, IRP (21 CFR 890.5650)	Same. Essential for regulatory pathway.
OTC or Rx	OTC	OTC	Same.
Environment of Use	Clinics, hospital, athlete training, and home environments	Clinics, hospital, athlete training, and home environment.	Same.
Standards	IEC 60601-1:2014; IEC 60601-1-2:2014	ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012; IEC 60601-1-2 Edition 4.0 2014-02	Same. Compliance with recognized safety standards is an acceptance criterion.
Biocompatibility	EN ISO 10993-5:2009 & EN ISO 10993-10:2010	Not required for subject device, as users wear clothing under the garments. No direct contact.	Different. Justification provided that direct patient contact is avoided, making biocompatibility not required and thus substantially equivalent.
Mode of Compression	Sequential/Peristaltic	Sequential "Seawave"/ Peristaltic	Same. Fundamental functional characteristic.
Max Pressure / Min Pressure	0-200 mmHg	0-119 mmHg	Different. Subject device provides substantially equivalent pressure despite the different maximum pressure. This is an accepted difference based on the intent of the device.
Number of Chambers	4 Chambers	4 Chambers	Same.
Compression Garment Material	Nylon with a Polyurethane laminate	Nylon with a Polyurethane laminate	Same.
Therapy Time	User determines; 10, 20, or 30 min, with option to add 10 min.	User determines; 10, 20, 25 or 30 min.	Same. Minor variation in specific time increments is considered substantially equivalent for user-determined therapy.
Cycle Time	1 min 20 sec (80 sec)	Varies by program (e.g., Program 1: 50 / 38; Program 6: 80 / 68; Program 8: 260/140). Program 6 provides same 1st cycle time as predicate. All others offer substantially same cycle time, varying between 34-260 seconds (1st cycle) and 33-203 seconds (subsequent cycles).	Same and Different. The document argues differences are within the same order of magnitude and do not raise new concerns, making it substantially equivalent.
Modes (Inflation Sequences)	2 modes: "A" (bottom up, one at a time), "B" (bottom up, maintains pressure in lower chambers).	2 modes: "A" (bottom up, one at a time), "B" (bottom up, maintains pressure in selected chambers). The document also mentions "Mode seawave" with overlapping bands and pressure control, similar to Mode B's description.	Same. Both devices have sequential modes that are functionally similar. The detailed descriptions for "Mode seawave" clarify the equivalence of the underlying mechanism.
Safety Features	Button on display allows user to stop or pause therapy.	Button on display allows user to stop or pause therapy.	Same. Critical safety feature.
Technology	Compressor and valve system which sequentially inflates cells of appliance.	Compressor and valve system which sequentially inflates cells of appliance.	Same. Core technological principle.
Non-clinical Tests	IEC 60601-1; IEC 60601-1-2	IEC 60601-1, IEC 60601-1-2, Earth circuit continuity, leakage current, current absorption, main switch, air hose connector, delivered pressure, display function, programs, top card function, safety pressure switch intervention, maximum setting pressure, integrity of inflatable parts.	Compliance reported. Device complies with acceptance criteria, documenting safety and effectiveness on validation and production units. This serves as the "study" for non-clinical performance.

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

Sample Size (Test Set): The document states, "No clinical tests were conducted." Therefore, there is no "test set" in the context of human subjects or clinical data for performance evaluation.
Data Provenance: Not applicable, as no clinical tests were performed. The evidence for substantial equivalence relies on non-clinical testing and comparison of device specifications to the predicate device.

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

Not applicable, as no clinical tests were performed and no "ground truth" for a test set was established using expert consensus. The "ground truth" for demonstrating non-clinical safety is the compliance with recognized standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical tests were performed and no test set requiring adjudication was used.

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

Not applicable. This device is not an AI-assisted diagnostic or interpretation system that would typically involve human readers.

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

Not applicable. This device is a physical therapy device, not an algorithm or AI system subject to standalone performance evaluation in that sense. Its "standalone" performance is measured by its physical and electrical characteristics and compliance with safety standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is compliance with established engineering and electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2). The performance of the device against these standards serves as the ground truth for its safety and functional equivalence.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a "training set."

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

Not applicable, as there is no training set for this type of device.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the (implicit) acceptance criteria consists of non-clinical tests and comparison to a predicate device.

Non-Clinical Tests:
- Tests Performed: Earth circuit continuity test, leakage current, current absorption, main switch, air hose connector, delivered pressure, display function, programs functionality, top card functionality, safety pressure switch intervention, maximum setting pressure, integrity of inflatable parts.
- Findings: "device complies with the acceptance criteria of these various tests, documenting that safety and effectiveness are achieved on validation units and on production units (tests are conducted on on-going basis)." This indicates that the device's physical, electrical, and functional characteristics meet the established benchmarks for safety and performance required by the relevant standards (ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012; IEC 60601-1-2 Edition 4.0 2014-02).
Predicate Device Comparison:
- The core "study" for substantial equivalence is the detailed comparison of the IAF-SYSTEM to the Rapid Reboot Compression Therapy System (K182668) across all critical aspects (indications for use, technological characteristics, safety features, operational parameters, etc.).
- The conclusion drawn is that "The technological characteristics are substantially equivalent to the predicate device, meeting the same technical standards." Any differences (e.g., max pressure, cycle time, biocompatibility where not required) are justified as not raising new questions of safety or effectiveness.

In summary, the FDA clearance for the IAF-SYSTEM is based on a demonstration of substantial equivalence to an already legally marketed device through a comprehensive comparison of specifications and compliance with recognized non-clinical safety and performance standards, rather than a clinical study with a test set of human subjects.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

August 22, 2022

Foggiare Technologies LLC % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K201730

Trade/Device Name: IAF-SYSTEM Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: July 6, 2022 Received: July 7, 2022

Dear Jay Mansour:

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

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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,

Tushar Bansal, PhD Acting 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

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Indications for Use

510(k) Number (if known) K201730

Device Name IAF-SYSTEM

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) #K201730

510k Summary:

As required by 21 CFR 807.92 (c)

1 - Date Summary Prepared: August 13, 2022

2 Owner/Submitter/Sponsor/Applicant information:

OWNER/SUBMITTER/SPONSOR/APPLICANT

Contact name: Edouard Sezionale- Foggiare Technologies LLC Title: owner/CEO Telephone: (561) 923-9161 Email address: thierry@foggiare.com Address: 426 E Palmetto Park Rd. Boca Raton, FL 33432 USA

APPLICATION CORRESPONDENT

Contact name: Jay Mansour, MSQA, BE, RAC- Mansour Consulting LLC Title: regulatory consultant- Principal Telephone: (678) 908-8180 Email address: jay@mansourconsulting.com Address: 845 Aronson Lake Court Roswell, GA 30075 USA

3 - Device Information:

Common/usual/classification name:

massager, powered inflatable tube

Device name:

	Device Model Name	Model Number
1	IAF-SYSTEM	(NO MODEL NUMBER)

FDA 3 Letter Code	IRP
FDA regulation number: 21 CFR	890.5650
Regulation medical specialty	Physical Medicine
Review panel	Physical Medicine
Class	2

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4 - Substantial equivalency is claimed against the following predicate device(s):

510kNumber	Trade or Proprietary or Model Name	Manufacturer	Primary Predicate
K182668	Rapid Reboot Compression Therapy System	Rapid RebootRecoveryProducts, LLC	Yes

5 - Description of the device

6 - Intended Use + indications for use

Intended Use:	The IAF-SYSTEM is intended for the temporary relief of minor muscle achesand pains and for the temporary increase in circulation to the treated areas in
indications for use:	people who are in good health. The IAF-SYSTEM simulates kneading andstroking of tissues by using an inflatable garment.

7 - Basis for determination of substantial equivalency:

(a) Indications for use:

The indication for use is identical to the predicate's.

(b) Technological characteristics:

The technological characteristics are substantially equivalent to the predicate device, meeting the same technical standards.

Substantial equivalency between our device and predicate device is tabulated below:

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Device	Subject DevicePrimary Predicate		Comparison
Manufacturer	DAM SRL	Rapid Reboot RecoveryProducts, LLC	NA
510(k)Number	TO BE DETERMINED	K182668	NA
Model Name	IAF-SYSTEM	Rapid Reboot CompressionTherapy System	NA
Classification	Class II Device,IRP (21 CFR890.5650)	Class II Device, IRP (21 CFR890.5650)	Same
Indications forUse (IFU)	The IAF-SYSTEM is intended for thetemporary relief of minor muscle achesand pains and for the temporary increasein circulation to the treated areas inpeople who are in good health. The IAF-SYSTEM simulates kneading and strokingof tissues by using an inflatable garment.	The Rapid RebootCompression Therapy System isintended for the temporary relief ofminor muscle aches and pains and forthe temporary increase in circulationto the treated areas in people whoare in good health. The Rapid RebootCompression Therapy Systemsimulates kneading and stroking oftissues by using an inflatablegarment.	Same
OTC or Rx	OTC	OTC	Same
Environmentof Use:	Clinics, hospital, athlete training, andhome environment.	Clinics, hospital, athlete training, andhome environments	Same
Standards	ANSI AAMI ES60601- 1:2005/ (R)2012 AndA1:2012IEC 60601-1-2 Edition 4.02014-02	IEC 60601-1:2014; IEC60601-1-2:2014	Same
	Biocompatibility not required	EN ISO 10993-5:2009 & EN ISO10993-10:2010	Different.Biocompatibilitynot required forsubject device, asusers wearclothing underthe garments. Nodirect contact
Mode ofCompression	Sequential"Seawave"/ Peristaltic	Sequential/Peristaltic	Same
PowerSource	120 V, 50Hz	120V, 60Hz	Same

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Therapy Time	User determines therapytime. Choose from 10, 20,25 or 30minute session time.	User determines therapytime. Choose from 10, 20, or 30minute session time, with optionto add additional 10 minutes toany therapy time.	Same
Max PressureMin Pressure	0-119 mmHg	0-200 mmHg	Different.Subject deviceprovidessubstantiallyequivalentpressure, despitethe differentmaximumpressure
Number ofChambers	4 Chambers	4 Chambers	Same
CompressionApplicatorGarmentsSleeveMaterial	Nylon with a Polyurethane laminate	Nylon with a Polyurethanelaminate	Same
HousingMaterialsAndConstructions	Molded ABS enclosure	Molded ABS enclosure	Same
Patient contact	Non-conductive attachments	Non-conductive attachments	Same
PowerConsumption	400 W	30W	Different due tophysicalconfiguration

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Leg (consisting of foot, calf, knee, upper						1 min 20 sec	Same and different
leg)							depending on the
The cycle time for all programs is							program. See
tabulated below.							below.
The first cycle can be different from the
following ones, because it starts with							Information below
					totally empty sectors, while the following		lists 1st cycle,
	cycles can start with some air in the						subsequent cycle

	cycles change over the course of the				sectors; moreover, in many programs the		and predicate cycle,respectively, all in

	program. This is illustrated within the						seconds, comparing
	user manual.minutes						each of the 12
							programs with the
Prog.	Treatment	Sector	cycle	cycle	subsequent		predicate cycle
n.ਹੈ	time25	pauseਹ	pause3	time50	cycle time38		time:
2	25	1	3	47	ਚ ਹ		Program 1: 50 / 38 / 80
m	25	ਹੈ	3	ರೇ	33		Program 2: 47 / 41 / 80
বাঁ			4	ਚਰੇ			Program 3: 46 /33 / 80
	25	2			ਤੌਰੇ		Program 4: 49 / 39 / 80
ട	25	2	4	ਦਰੇ	eo		Program 5: 69 / 60 / 80
б	25	2	4	80	e8		Program 6: 80 / 68 / 80
7	25	1	3	97	35		Program 7: 97 / 35 / 80
8	30	1	3	260	140		Program 8: 260/140/80
							Program 9: 65 / 98 / 80
ਰੇ	25	ਹ	3	દર	ಕಿ8		Program 10: 206/203/80
10	20	2	4	206	203		Program 11: 34 / 28 /80Program 12: 34 / 33 / 80
11	30	2	3	34	28
12	20	2	3	34	33		Program 6 provides the
							same exact (1st) cycle
					The cycle time is the time needed to fill air in		time as predicate device.
	the sectors with set pressure in the set
	sequence + sectors pause.						All other programs offer
							substantially the same
					Sector pause is the time between the end of		cycle time, varying
					fill in of air in a sector and the start of fill in		between 34 and 260
	of the air in the sequel one.						seconds (for 1st cycle) and
					The cycle pause is the time between the end		between 33 and 203
	of a cycle and the start of the next one.						seconds (for subsequent
					1st cycle time is the time needed for the 1st	3	cycles).
	complete cycle (it needs a little more						The differences in cycle
	because start with total empty sectors).						times are within the
					Subsequent cycle time is the time need for		same order of magnitude
					other cycles ( being little bit shorter because		as predicate device, and
	the sectors are not totally empty).						do not raise new
	Exception in program 9: This program						concerns.
	includes a first section where the plantar

thrust provides pressure starting from thebottom-base of the thigh, then mid-thigh,
then knee and calf, and finally knee and
ankle. The effect is therefore drainage from
the top. After that, it starts a treatment like
program 1.

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Size	49″ x 21″ x 14.5″	10″ x 6.5″ x 5″	Same.(Tabletop orhandheld portable)
Weight	77 pounds with base	5.8 pounds	Different due to physicalconfiguration
Modes (Inflationsequences, allpreprogrammed)	2 modes: "A" mode inflates and deflateschambers from bottom up (distal toproximal chambers), one at a time. "B"mode also inflates chambers frombottom up, but maintains pressure inselected chambers as works its way totop. Then all chambers release pressureat same time once all chambers havesequentially inflated.	2 modes: "A" mode inflates anddeflates chambers from bottom up(distal to proximal chambers), oneat a time. "B" mode also inflateschambers from bottom up, butmaintains pressure in lowerchambers as works its way to top.Then all chambers release pressureat same time once all chambershave sequentially inflated.	Same.Both devices havesequential mode(distal toproximalchambers).

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"Sequential:"	Mode A:	Same
With "lock" on specific area
Mode seawave:	Mode B:	SameThe machinepermits applyinga set pressure ina targeted wayto each single"lock" sector todetermine theeffect andeffectiveness onthe patient.One or moresectors can bekept underpressure so thatduring programexecution, thesedo not deflateduring the cycle.
"SEA WAVE" LEG-PIECEWith overlapping bands, pressure which decreases towardsthe top and programmable control of sectors,the flow is physiological.

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"Leg" Attachment	Leg (consisting of foot, calf, knee, upper leg)	Leg (consisting of foot, calf, knee, upper leg)	Same
Leg AttachmentPhotos	Image: Leg attachment photo	Image: Leg attachment photo	Same
Leg AttachmentSizes	51"x 26"	X-Short: 14" x 41"Short: 14" x 43"Medium: 14" x 45"Long: 14" x 48"X-Long: 14" x 52"	Different.Slight variation.
"Hip" Attachment	Hip (consisting of upper legs, glutes, hips, lower back)	Hip (consisting of upper legs, glutes, hips, lower back)	Same

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"Arm"Attachment	Arm (consisting of entirearm, shoulder, upper chest and back)	Arm (consisting of entire arm,shoulder, upper chest and back)	Same
Arm AttachmentPhotos	66 cm72 cm		Same.
Arm AttachmentSizes	One size: 26" x 28 "72 cm65 cm	Regular: 18" x 38"Long: 18" x 44"	Same.Slightvariation.
Safety Features	Button on display allows user to stop orpause therapy session at any time.	Button on display allows user tostop or pause therapy session atany time.	Same
SW/Firmware/MicroprocessorControl	Microprocessor	Microprocessor	Same
Technology	Compressor and valve system whichsequentially inflates cells of appliance	Compressor and valve systemwhich sequentially inflates cells ofappliance	Same

Safety testing and EMC testing successfully completed. In particular, the following tests were performed:

1- Earth circuit continuity test, leakage current, current absorption, current absorption: Summary of findings- device complies with these IEC 60601-1 safety requirements, in the lab as well as on production units (tests are conducted on on-going basis).
2- Main switch, air hose connector, delivered pressure, display function, programs, top card function, safety pressure switch intervention, maximum setting pressure, integrity of the inflatable parts (multiple)

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Summary of findings- device complies with the acceptance criteria of these various tests, documenting that safety and effectiveness are achieved on validation units and on production units (tests are conducted on on-going basis).

(d) Clinical tests- brief discussion

Not applicable. No clinical tests were conducted.

(e) Non-clinical and clinical tests- conclusions drawn demonstrating that the device is as safe and as effective, and performs as well as the predicate device(s): Safety of subject device is confirmed via testing. Effectiveness is ensured by similar parameter of a well-understood device mechanism.

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).