The Portable Air Massager putifino AM-7 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 Portable Air Massager putifino AM-7 simulates kneading and stroking of tissues by using an inflatable garment (Cuff).

Device Description

Portable Air Massager putifino AM-7 is a powered inflatable tube massager, which stimulates kneading and stroking of tissues with the hands by pressurizing and depressurizing the massaging garment (cuff) wrapped around the calf. The cotton and velour massaging cuff with inflatable bladder inside is assembled to the controller to facilitate the device's compactness and portability. The device is applicable to calves whose circumferences are between 8.7 to 17.7 inches (22 to 45 cm). With the included attachable extension hook, the applicable range extends to 19.7 inches (50 cm). The device owns three modes of massage pattern and three levels of massage intensity, which are controlled by the microprocessor. Operation of the mode button on the controller during massaging will switch the massage patterns. In MODE 1, massage is given by repetition of pressurization and depressurization of the cuff, where pressurization is set to one pressure level. In MODE 2, massage pattern of MODE 1 is repeated at two pressure levels. In MODE 3, which is intended to temporary increase blood circulation, approximately 10 minutes of massage at low pressure level and approximately 20 minutes of rest are repeated. In MODE 1 and 2, operation of the pressure button on the controller will switch the massage intensities: weak, moderate and hard. The user of the device can confirm both massage mode and level with the illuminated indicator on the controller.

AI/ML Overview

The Portable Air Massager putifino AM-7 is a Class II device (21 CFR 890.5650 - Powered inflatable tube massager) 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. It simulates kneading and stroking of tissues using an inflatable garment (cuff).

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study. Substantial equivalence is established by comparing the technological characteristics and indications for use of the new device to a legally marketed predicate device. Therefore, a traditional study proving the device meets specific acceptance criteria as you might see for a novel, high-risk device is not presented in this document. Instead, the "study" is the comparison itself, which aims to show that the new device is as safe and effective as the predicate.

Here's an analysis of the provided information in the context of substantial equivalence:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for novel performance metrics in the way a clinical trial would define them. Instead, the acceptance criteria are implicit in demonstrating that the device's technological characteristics and intended use are similar enough to a predicate device that it raises no new questions of safety or effectiveness.

The table below summarizes the comparison between the subject device (Portable Air Massager putifino AM-7) and the predicate device (Salton, Inc., Relaxor Perfect Touch Air Massaging System K050697), highlighting the similarities that establish substantial equivalence.

Feature / Acceptance Criteria (Implicit for Substantial Equivalence)	Subject Device: Portable Air Massager putifino AM-7 Performance	Predicate Device: Relaxor Perfect Touch Air Massaging System Performance	Outcome (Meets Acceptance Criteria)
Indication for Use	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. Simulates kneading and stroking of tissues using an inflatable garment (Cuff).	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. Simulates kneading and stroking of tissues using an inflatable garment.	Meets: Identical indications for use.
Operational Principle	Provides massage by inflating and deflating the bladder inside a massaging garment with an air pump and electric control valve.	Provides massage by inflating and deflating a massage garment.	Meets: Same fundamental mechanism of action.
Massage Mode/Pattern	3 massage patterns (Mode 1, Mode 2, Mode 3 - Blood circulation improvement mode).	Not explicitly "patterns" but "Press Zone" and ability to specify massage areas through garments with separated chambers (which the subject device doesn't have). Allows "Intermittent" compression.	Meets: Both use intermittent compression. Differences in specific patterns are considered "product features" that do not affect substantial equivalence.
Massage Intensity/Level	3 massage levels (Weak, Moderate, Strong).	6 massage levels.	Meets: Both offer variable intensity; difference in number of levels not considered a fundamental safety/effectiveness difference.
Massage Pressure Range	Specified pressures for each mode/intensity (e.g., Mode 1: Weak 9.3kPa (70mmHg), Moderate 13.3kPa (100mmHg), Strong 17.3kPa (130mmHg); Mode 2: Weak 70/80mmHg, Moderate 100/110mmHg, Strong 130/140mmHg; Mode 3: 6.0kPa (45mmHg)). Overall pressure range: 0-200mmHg.	Intensity Settings 1-6 with corresponding pressures: 80, 104, 128, 152, 176, 200 mmHg. Overall pressure range: 0-250mmHg.	Meets: Both operate within a comparable and safe pressure range for massager devices, with overlapping pressure values. The maximum pressure of the subject device (200mmHg) is within the predicate's range (0-250mmHg).
Intermittent Compression	Yes	Yes	Meets: Both use intermittent compression.
Massage Time	Mode1: 10 minutes; Mode2: 10 minutes; Mode3: Approx. 10 mins massage / 20 mins rest (repeated).	15 minutes.	Meets: Pre-set timer functionality is similar. Differences in specific durations are not considered to raise new safety/effectiveness questions.
Massage Part	Calves	Leg & Foot, Feet, Arm, Neck & Shoulders, Lower Back, Hands.	Meets: While the subject device is for calves only, this narrowing of application does not represent a new safety/effectiveness concern. Both are for limb/body massage.
Number of Chambers	1	1 to 12, Varies with Garments.	Meets: The subject device's single chamber simplifies its design but does not introduce new risks compared to multi-chamber systems.
Material (Operation Unit)	ABS	ABS	Meets: Same material for operation unit.
Material (Massage Garment)	Surface: Cotton / Polyester / Nylon; Back: Velour (for the cuff).	TPU; Nylon with TPU Backing 190X70 with TPU Backing.	Meets: Different materials but both are common, biocompatible textiles/plastics used in medical devices and are not expected to cause new safety concerns.
Pressure Control	Microprocessor and Pressure Sensor.	Microprocessor.	Meets: Both use microprocessor control. The addition of a pressure sensor in the subject device enhances control rather than creating a new safety risk.
Inflation Mechanism	Pressurization pump.	Pressurization pump.	Meets: Same inflation mechanism.
Deflation Mechanism	Electronic control exhaust valve.	Exhaust valve.	Meets: Both use an exhaust valve; electronic control is an enhancement, not a new risk.
Power Source	2 x 1.5-Volt "AA" Alkali battery, Consumption 2W. Designed for portability.	Main body: 120V 60Hz, Consumption 26W; AC Adapter: 120V 60Hz, Consumption 36W.	Meets: Different power sources (battery vs. AC) but both are standard and safe for consumer electronics. The portability via batteries is a design difference, not a new safety concern.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission is a 510(k) for substantial equivalence and does not involve a "test set" in the context of clinical performance data collection. Instead, it relies on a comparison of technical specifications and indications for use against a predicate device that is already legally marketed. There is no specified sample size, data provenance, or retrospective/prospective study design in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As explained above, there is no "test set" or "ground truth" derived from expert consensus in this type of 510(k) submission. Substantial equivalence is determined by regulatory review of documented technical specifications and comparison to the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication method described in the document. The FDA's review process determines substantial equivalence.

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 a powered inflatable tube massager. It is a physical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to its purpose and regulatory pathway.

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

Not applicable. This is not an algorithm or AI device. Its performance is inherent in its electromechanical operation.

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

Not applicable. For a device seeking substantial equivalence, the "ground truth" is typically the established safety and effectiveness profile of the legally marketed predicate device. The new device is deemed safe and effective if it does not introduce new questions of safety or effectiveness compared to the predicate.

8. The sample size for the training set

Not applicable. This is a 510(k) for substantial equivalence, not an AI/machine learning device requiring training data.

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

Not applicable. There is no training set for this device.

Summary

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K071596

1. Company Identification

NIHON SEIMITSU SOKKI CO., LTD. (Nissei) 2508-13 Nakago, Shibukawa, Gunma 377-0293 Japan Tel: +81-279-20-2311 Fax: +81-279-20-2411

2. Official Correspondent

Hideki Tomaru (Mr.) Assistant Manager of International Sales Div.

3. Date of Submission

June 11, 2007

4. Trade/Proprietary Name

Portable Air Massager putifino AM-7

5. Classification Number

Class II, IRP, 21 CFR 890.5650 - Powered inflatable tube massager

6. Predicate Device

Manufacturer : Salton, Inc Trade Name : Relaxor Perfect Touch Air Massaging System : K050697, Cleared on April 10, 2003 510(k) No.

7. Description of Device

The device owns three modes of massage pattern and three levels of massage intensity, which are controlled by the microprocessor. Operation of the mode button on the controller during massaging will switch the massage patterns. In MODE 1, massage is given by repetition of pressurization and depressurization of the cuff, where pressurization is set to one pressure level. In MODE 2, massage pattern of MODE 1 is repeated at two pressure levels. In MODE 3, which is intended to temporary increase blood circulation, approximately 10 minutes of massage at low pressure level and approximately 20 minutes of rest are repeated. In MODE 1 and 2, operation of the pressure button on the controller will switch the massage intensities: weak, moderate and hard. The user of the device can confirm both massage mode and level with the illuminated indicator on the controller.

8. Indication for use

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9. Technological characteristics of the subject device

The device, powered with two AA alkaline batteries, achieves its intended use by inflating and deflating the bladder inside the massaging garment with the air pump and the electric control valve. The microprocessor controls inflation and deflation of the bladder to conduct message in three different modes and to provide massage at different intensities.

The comparison table of the technological characteristics of the predicate device and the subject device is attached as Appendix 1.

The predicate and subject devices share the same operational principal, that is, to provide massage by inflating and deflating massage garment wrapped around a part of the body. The differences between the devices arise in product features due to mechanical structures that the subject device is designed to be portable. The product features of the predicate device to change massage garments as mentioned above and to specify massage areas, which is enabled with the garment with separated chambers, are not equipped with the subject drevice, The other difference due to the structure is that the devices are operated with different power sources; the predicate is powered by AC adapter and the subject device by batteries. Although the product features are not identical, these characteristic differences should not affect the substantial equivalence of the subject device to the predicate device.

10. Conclusion

The Portable Air Massager putifino AM-7 is substantially equivalent to Salton, Inc., Relaxor Perfect Touch Air Massaging System K050697.

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Appendix 1: Comparison Table with Predicate Device

SUBJECT DEVICE:AM-7	PREDICATE DEVICE:K030437
INDICATION FOR USE	INDICATION FOR USE
The Portable Air Massager putifino AM-7 isindicated for the temporary relief of minormuscle aches and pains and for temporaryincrease in circulation to the treated areas inpeople who are in good health. The Portable AirMassager putifino AM-7 simulates kneading andstroking of tissues by using an inflatablegarment (Cuff).	The Perfect Touch Air Massaging System isindicated for the temporary relief of minormuscle aches and pains and for temporaryincrease in circulation to the treated areas inpeople who are in good health. The PerfectTouch simulates kneading and stroking oftissues by using an inflatable garment.
INDICATIONS	INDICATIONS
PowerPressureModeMODE OF COMPRESSION	SpeedIntensityPress ZoneMODE OF COMPRESSION
Intermittent	Intermittent
MASSAGE OPERATION	MASSAGE OPERATION
Massage level:3 (Weak, Moderate, Strong)Massage pattern:3(Mode1, Mode2, Mode3)Mode3 is Blood circulation improvement mode	Speed:10 Speed settingsMassage level:6 LevelsZone:16Zone
MASSAGE TIME	MASSAGE TIME
Mode1: 10 minutesMode2: 10 minutesMode3: Approximately 10 minutes ofmassage and approximately 20 minutes ofrest are alternately repeated.	15 minutes
MASSAGE PRESSURE	MASSAGE PRESSURE
Massage Pattern is Mode1:Weak:9.3kPa (70mmHg)Moderate:13.3kPa (100mmHg)Strong:17.3kPa (130mmHg)	Intensity Settings 1 2 3 4 5 6 Garment Air Pressure 80 (mmHg) 104 (mmHg) 128 (mmHg) 152 (mmHg) 176 (mmHg) 200 (mmHg)
Massage Pattern is Mode2:Weak:9.3kPa (70mmHg),10.7kPa(80mmHg)Moderate:13.3kPa(100mmHg),14.7kPa(110mm Hg)Strong:17.3kPa(130mmHg),18.7kPa(140mmHg)
Blood stream improvement with Mode3:Pressure is keep at 6.0kPa (45mmHg)MASSAGE PART	MASSAGE PART
Calves	Leg & Foot, Feet, Arm,Neck & Shoulders, Lower Back, Hands
PRESSURE RANGE	PRESSURE RANGE
0-200mmHg	0-250mmHg

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SUBJECT DEVICE:AM-7	PREDICATE DEVICE:K030437
NUNBER OF CHAMBERS	NUNBER OF CHAMBERS
1	1 to 12, Varies with Garments
MATERIAL	MATERIAL
Operation Unit: ABSMassage Garment: Surface: Cotton / Polyester /NylonBack: Velour	Operation Unit: ABSMassage Garment: TPUNylon with TPU Backing 190X70 with TPUBacking
Pressure control	Pressure control
Microprocessor and Pressure Sensor	Microprocessor
Inflation	Inflation
Pressurization pumpDeflation	Pressurization pumpDeflation
Electronic control exhaust valve	exhaust valve
POWER SOURCE	POWER SOURCE
2×1.5-Volt"AA" Alkali batteryConsumption 2W	Main body:120V 60HzConsumption 26WAC Adapter:120V 60HzConsumption 36W

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Public Health Service

FEB 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nihon Seimitsu Sokki Co., Ltd. % Cosmos Corporation Mr. Koji Kubo Manager 3F, 2-17-6 Akebono-cho Tachikawa-shi Tokyo 190-0012 Japan

Re: K071596

Trade Name: Portable Air Massager putifino AM-7 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager. Regulatory Class: Class II Product Code: IRP Dated: January 12, 2008 Received: January 16, 2008

Dear Mr. Kubo:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set

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Mr. Koii Kubo

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K071596

Device Name : Portable Air Massager putifino AM-7

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K071596

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).