The Normatec 3 is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

Device Description

The Normatec 3 is a powered inflatable tube massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-2 compliant lithium-ion battery.

The user interface on the Normatec 3 is a series of buttons with one small display the treatment time. The user interface provides for:

Starting and stopping the massage treatment; .
Adjusting time and intensity (pressure) of the treatment; .
Selection of Attachment in use (Leg, Arm, Hip); .
. Selection of Zone Boost which provides an increase of 10 mm Hg to the Zone selected

In addition to the user interface on the devices the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called Normatec 3. It compares the Normatec 3 to a predicate device (NormaTec Pulse 2.0 and Pulse Pro 2.0, K183169) 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 present a formal table of acceptance criteria with specific performance metrics and their corresponding reported device performance values. Instead, it asserts substantial equivalence based on a comparison of characteristics between the proposed device (Normatec 3) and the predicate device (NormaTec Pulse 2.0 / Pulse Pro 2.0).

The "acceptance criteria" are implicitly met by demonstrating that the Normatec 3 is substantially equivalent to the predicate device across various aspects. The "reported device performance" is essentially the demonstrated equivalence to the predicate's performance and compliance with relevant standards.

Here's a summary derived from the provided text:

Characteristic / Acceptance Criterion (Implicit)	Reported Device Performance (Normatec 3)
Indications for Use: Temporary relief of minor muscle aches and/or pains, and temporary increase in circulation to treated areas.	Identical to the predicate device (NormaTec Pulse 2.0 and Pulse Pro 2.0, K183169).
Regulatory Classification: OTC device.	OTC device, same as the predicate.
Design, Technology, and Principle of Operation: Equivalent design and features, similar technology (compressor and valve system for sequential inflation, Bluetooth capability for app control).	Equivalent design and features, similar technology. Bluetooth app functions only as an alternative user interface and does not add new features or affect therapy.
Performance and Specifications: Equivalent specifications of performance (e.g., Device Pressure Range 0-110 mmHg, Pressure Levels, ZoneBoost, Inflation/Deflation Cycle Type, Appliance Contact Surface Material, Number of Inflatable appliance segments, Weight = 3.6 lbs, Housing Materials, Patient contact).	Equivalent specifications of performance to the predicate. Minor differences, such as changed treatment setup times to a max of 60 minutes (instead of continuous), do not raise new safety or effectiveness concerns. Power On recalls last used settings for treatment time and pressure levels. Displays battery level and charging status.
Compliance with Voluntary Standards: AAM ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and ANSI C63.27-2017.	Complies with AAM ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and ANSI C63.27-2017. Also includes IEC 60601-1-6 compliance (which does not raise new safety concerns).
Materials: Patient-contacting materials (inflatable appliances).	Identical to the predicate device (200 denier nylon with a polyurethane laminate/extrusion).
Intended Use Environment: Clinics, hospital, athlete training, and home environments.	Identical to the predicate.
Features: Equivalent features, including user interface for starting/stopping, adjusting time/intensity, selecting attachments, Zone Boost, remote operation via Bluetooth app, battery charging display, power off, appliance selection, and various treatment monitoring functions (timers, counters).	Equivalent features. The Normatec 3's user interface is a series of buttons with a small display for treatment time. The Bluetooth app provides an alternative way to control device parameters. Some minor differences in treatment mode availability (e.g., NormaTec Pulse vs. Sequential, Recovery Flush, Rehab, Custom on Pulse Pro 2.0). However, overall features are considered equivalent for substantial equivalence.
Safety and Effectiveness: No new questions of safety or effectiveness are raised by the differences between the proposed device and the predicate device.	Verification and Validation activities performed demonstrated that the proposed device meets defined requirements and performance claims, and that it is as safe, as effective, and performs as well as the predicate device. Minor differences (e.g., treatment time changes, additional 60601-1-6 compliance) do not raise new safety concerns.

2. Sample size used for the test set and the data provenance

The document does not specify a numerical sample size for a test set that would typically be used in a clinical study to evaluate device performance against specific clinical acceptance criteria.

The evaluation for the Normatec 3's substantial equivalence appears to rely primarily on non-clinical testing to demonstrate compliance with standards and equivalence to the predicate device. The text states:

"Verification and Validation activities required that establish the performance, functionality, and reliability characteristics of the Normatec 3 with respect to the predicate were performed."
"Testing performed demonstrated that the proposed device meets defined requirements and performance claims."
"The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as the predicate device..."

This suggests engineering and bench testing rather than human subject testing to generate a "test set" in the context of clinical performance data. Therefore, data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here as a distinct clinical test set is not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/not provided. The assessment for the Normatec 3 is based on engineering and performance comparisons, and compliance with standards, rather than expert-adjudicated clinical data to establish a "ground truth."

4. Adjudication method for the test set

This information is not applicable/not provided for the same reasons as point #3. There is no mention of a human-reviewed "test set" requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers interpret medical images or data. The Normatec 3 is a physical therapy device (powered inflatable tube massager) and does not involve human readers interpreting medical cases. Furthermore, it is not an AI-assisted device in the context typically seen in MRMC studies.

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

A standalone performance study in the context of an algorithm's diagnostic accuracy is not applicable and was not done. The Normatec 3 is a physical device, and while it has software/firmware and Bluetooth control, its core function is physical massage, not algorithmic diagnosis or interpretation. The "algorithm" here controls the physical inflation/deflation cycle.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology for cancer detection, expert consensus on imaging findings) is not directly applicable in this submission.

Instead, the "ground truth" for the device's performance is implicitly established by:

Compliance with recognized voluntary standards (e.g., IEC 60601 series for electrical medical equipment safety).
Engineering specifications and measurements demonstrating the device performs within expected physical parameters (e.g., pressure range, cycle type).
Equivalence to the legally marketed predicate device, implying that if the predicate is safe and effective, and the new device is substantially equivalent, then it also meets safety and effectiveness criteria.

8. The sample size for the training set

This information is not applicable/not provided. The Normatec 3 is a physical device with embedded software; it is not primarily an AI/machine learning model that undergoes "training" on a dataset in the typical sense. Its control logic is programmed, not learned via large data sets.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the same reasons as point #8. There is no mention of a traditional "training set" or "ground truth" establishment for training in this 510(k) submission.

Summary

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February 25, 2022

NormaTec Industries, LP % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K220217

Trade/Device Name: Normatec 3 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: January 25, 2022 Received: January 26, 2022

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 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

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Indications for Use

510(k) Number (if known) K220217

Device Name Normatec 3

Indications for Use (Describe)

The Normatec 3 is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

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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NormaTec Industries, LP

Date of Preparation:	February 22, 2022
480 Pleasant StreetSuite A200Watertown MA 02472	Tel - 800.355.0960Fax - 866.279.2579
Official Contact:	Steve Henderson, Quality Systems and Regulatory Manager
Proprietary or TradeName:	Normatec 3
Subject Device:	Normatec 3
Common/Usual Name:	Massager, Powered Inflatable Tube
Classification Name	Powered inflatable tube massager
Regulation Number:	21 CFR 890.5650
Product Code:	IRP
Regulation MedicalSpeciality:	Physical Medicine
Predicate Device:	K183169 – NormaTec Pulse 2.0 and Pulse Pro 2.0
Classification Name	Powered inflatable tube massager
Common/Usual Name	Massager, Powered Inflatable Tube
Regulation Number:	21 CFR 890.5650
Product Code	IRP
Regulation MedicalSpeciality:	Physical Medicine

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Device Description

The user interface on the Normatec 3 is a series of buttons with one small display the treatment time. The user interface provides for:

Starting and stopping the massage treatment; .
Adjusting time and intensity (pressure) of the treatment; .
Selection of Attachment in use (Leg, Arm, Hip); .
. Selection of Zone Boost which provides an increase of 10 mm Hg to the Zone selected

Intended User

ОТС

Patient Population

Adults

Indications for Use

The NormaTec Normatec 3 is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Intended Use Environment:

Clinics, hospital, athlete training, and home environments.

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510(k) Summary Page 3 of 9

Table 1 – Table of Device Comparisons and Differences

	Predicate Device	Proposed New Device	Comment	Characteristic	Pulse 2.0 / PulsePro 2.0	Normatec 3
Model Name510(k) Number	NormaTec Pulse 2.0 and Pulse Pro 2.0510(k) K183169	Normatec 3510(k) K220217	N/A	Power On - The system recalls and displays the last used settings for:
Manufacturer	NormaTec Industries, LP	Same	N/A	Treatment time	X	X
Prescriptive	No, OTC	Same	N/A	Treatment mode	X	N/A
Indications for use	The NormaTec Pulse 2.0 and PulsePro 2.0 are air pressure massagersintended to temporarily relieve minormuscle aches and/or pains, and totemporarily increase circulation to thetreated areas.	The NormaTec Normatec 3 is an airpressure massager intended totemporarily relieve minor muscle achesand/or pains, and to temporarilyincrease circulation to the treatedareas.	N/A	Therapy modeRehab mode - Recalls zone focusCustom - recalls all settingsRecovery Flush	Pulse 2.0 – N/APulse Pro 2.0 – X	N/A
Intended UseEnvironment	Clinics, hospital, athlete training, andhome environments	Same	N/A	RehabPreset NormaTec PULSE time / PULSE pressure valuesLeg appliance - Foot/ankle, calf, knee, lower quad, upper quadArm appliance - Hand/wrist, forearm, elbow, bicep, shoulderHip appliance - Quadriceps, hip	Pulse 2.0 – N/APulse Pro 2.0 – X	N/A
Power Source(s)	15 VDC via an IEC 60601-1compliant power supply (100- 240 VACinput)Integrated rechargeable battery	Same	N/A	Appliance Type	Pulse 2.0 – N/APulse Pro 2.0 – X	X
Software / FirmwareMicro-processorControl	Microprocessor	Same	N/A	Pressure Level	X	X
Technology	Compressor and valve system thatsequentially inflates cells of appliance.Bluetooth communication ability.	Same	N/A	Number of zones	X	X
Compliance withVoluntary standards	AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11 and ANSI C63.27-2017.	Same and includes IEC 60601-1-6compliance	The additional testing of 60601-1-6compliance does not raise any newdevice safety concerns	Rest time	X	x
	Predicate Device	Proposed New Device	Comment	Time
Device PressureRange	0-110 mmHg	Same	N/A	Add timeBefore treatmentDuring treatment	X	X
Pressure Levels	Level 1: 40 mm Hg maxLevel 2: 50 - 60 mm Hg maxLevel 3: 60 - 70 mm Hg maxLevel 4: 70 - 80 mm Hg maxLevel 5: 80 mm Hg maxLevel 6: 80 - 90 mm Hg maxLevel 7: 100 mm Hg max	Same	N/A	Decrease timeBefore treatmentDuring treatment	X	x
ZoneBoost	Provides an increase of 10 mm Hg tothe Zone selected	Same	N/A	Continuous mode	X	N/A
Treatment Time	Stays on until the user turns it off orcan be set up to turn off in a range of10 minutes to continuous	Stays on until the user turns it off orcan be set up to turn off in a range of15 minutes to 60 minutes	Changed setup times for treatment ofnew device to a max of 60 minutesinstead of continuous to match usertypical sessions with device.	Counter	X	X
Inflation/DeflationCycle Type	Sequential Gradient, Peristaltic andPulsing	Same	N/A	Count down - 1 second increments	X	X
Appliance ContactSurface Material	200 denier nylon with a polyurethanelaminate/extrusion	Same	N/A	Count up (continuous mode) - 1 second increments	X	N/A
Number of Inflatableappliance segments	5 or less	Same	N/A	Compliance - Trip meter	Pulse 2.0 – N/APulse Pro 2.0 – X	X
Weight	3.6 pounds (incl. battery)	Same	N/A	Chronometer Odometer - cannot be reset by User	X	X
Dimensions(W x H x D)	4.4" x 3.8" x 8.1"	4.17 x 3.66 x 8.25	N/A	Pressure
Housing Materialsand Constructions	Molded ABS enclosure (94V0)	Same	N/A
Patient contact	Non-conductive appliances	Same	N/A

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K220217

510(k) Summary

Page 4 of 9

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Differences Between Models

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K220217

510(k) Summary

Page 6 of 9

Characteristic	Pulse 2.0 / PulsePro 2.0	Normatec 3
Increase level
Before treatment	×	×
During treatment
Decrease level
Before treatment	×	×
During treatment
Characteristic	Pulse 2.0 / PulsePro 2.0	Normatec 3
Treatment Mode – Can ONLY be changed before treatment begins
NormaTec Pulse	X	X
Sequential	X	N/A
Rest Time
View or change rest time – before treatment	X	N/A
# of Zones
Change number of zones – before treatment	X	N/A
Treatment
Starting	X	X
Pause	X	X
Un-pause	X	X
End - If timer reaches 0:0000, treatment will continue until Rest periodis reached.	X	X
Remote operation via Bluetooth app	X	X
Battery Charging
Displays battery level	X	X
Displays when battery is charging	X	X
Power off
No treatment in process	X	X
Treatment is process	X	X
Appliance type
Select appliance – boot, arm, hipNOTE: If hip appliance is selected, treatment mode defaults to 2-zonetreatment	X	X
Therapy Mode
Recovery FlushPreset NormaTec PULSE time / PULSE pressure valuesAppliance type applicable - boot, arm, hip	Pulse 2.0 – N/APulse Pro 2.0 – X	N/A
RehabPreset NormaTec PULSE time / PULSE pressure valuesLeg appliance - Foot/ankle, calf, knee, lower quad, upper quadArm appliance - Hand/wrist, forearm, elbow, bicep, shoulderHip appliance - Quadriceps, hip	Pulse 2.0 – N/APulse Pro 2.0 – X	N/A
Characteristic	Pulse 2.0 / PulsePro 2.0	Normatec 3
Custom SettingsAllows user to program NormaTec PULSE pressure and time values foreach zonePressure range – 30-110 mmHg, user can select in 10 mmHgincrementsTime range - 15 seconds to 4 minutes, user can select in 15 secondincrements	Pulse 2.0 – N/APulse Pro 2.0 - Χ	N/A
Display Settings Adjustment
Brightness controls	Pulse 2.0 – N/APulse Pro 2.0 - Χ	N/A

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510(k) Summary Page 7 of 9

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K220217

510(k) Summary Page 8 of 9

Determination of Substantial Equivalence

The Normatec 3 is substantially equivalent to currently marketed and cleared devices (K183169) because:

Indications for Use

The Normatec 3 indications for use are identical to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0, 510(k) K183169.

Prescriptive

The Normatec 3 and the predicate (K183169) are OTC devices.

Design, Technology, and Principle of Operation

The Normatec 3 has equivalent design and features when compared to the predicate and have similar technology to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.

The proposed device has Bluetooth capability that allows the use of a NormaTec app to control the device. In addition to the user interface on the devices, the proposed device has Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

Performance and Specifications

The Normatec 3 has equivalent specifications of performance when compared to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.

Compliance with Standards

The predicate devices are compliant with AAM ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11 and ANSI C63.27-2017.

The Normatec 3 complies with AAM ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-2, IEC 60601-1-11 and ANSI C63.27-2017.

Materials

The patient-contacting materials of the Normatec 3 are the inflatable appliances that are identical to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.

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Intended Use Environment

Clinics, hospital, athlete training, and home environments, which are identical to the predicate.

Features

The Normatec 3 has equivalent features when compared to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.

Conclusion

The Normatec 3 is substantially equivalent to the predicate, NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169 in:

Patient population, .
Environment of use, .
. Technology characteristics,
Materials, ●
Specifications / performance, and .
Compliance with international standards. .

The inclusion of the Bluetooth capability and associated app does not affect the equivalency of the proposed devices and the predicate. The app functions only as an alternative user interface. No additional features are provided or unlocked by the app. Nor is the therapy provided by the devices affected by using the app.

Other minor differences as detailed in the substantial equivalence table do not raise questions of safety and effectiveness.

Indications for Use

The Normatec 3 Indications for Use and Contraindications are identical to the predicate NormaTec Pulse 2.0 and Pulse Pro 2.0 510(k) K183169.

Verification and Validation activities required that establish the performance, functionality, and reliability characteristics of the Normatec 3 with respect to the predicate were performed. Testing performed demonstrated that the proposed device meets defined requirements and performance claims.

The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as the predicate device according to 807.92(b)(3).

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).