(248 days)
Not Found
No
The device description details a microprocessor controlling pre-programmed massage patterns and intensity levels. There is no mention of learning, adaptation, or data-driven decision-making characteristic of AI/ML.
Yes
The device is indicated for "temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas," which are therapeutic claims.
No
The device is described as a massager intended for temporary relief of muscle aches and pains and increased circulation, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components including an inflatable garment (cuff), a controller, a microprocessor, and an attachable extension hook. It describes the physical interaction of these components to provide massage.
Based on the provided information, the Portable Air Massager putifino AM-7 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Portable Air Massager putifino AM-7 is a physical therapy device that applies external pressure to the calves. Its intended use is for temporary relief of muscle aches and pains and temporary increase in circulation.
- The device description clearly outlines a mechanical action (pressurizing and depressurizing a cuff) applied externally to the body.
There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
IRP
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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.
8. Indication for use
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).
FEB 15 =======================================================================================================================================================================
1
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.
2
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 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). | The Perfect Touch Air Massaging 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 Perfect | |||||||||||||||
| Touch simulates kneading and stroking of | |||||||||||||||
| tissues by using an inflatable garment. | |||||||||||||||
| INDICATIONS | INDICATIONS | ||||||||||||||
| Power | |||||||||||||||
| Pressure | |||||||||||||||
| Mode | |||||||||||||||
| MODE OF COMPRESSION | Speed | ||||||||||||||
| Intensity | |||||||||||||||
| Press Zone | |||||||||||||||
| MODE 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 settings | ||||||||||||||
| Massage level:6 Levels | |||||||||||||||
| Zone:16Zone | |||||||||||||||
| MASSAGE TIME | MASSAGE TIME | ||||||||||||||
| Mode1: 10 minutes | |||||||||||||||
| Mode2: 10 minutes | |||||||||||||||
| Mode3: Approximately 10 minutes of | |||||||||||||||
| massage and approximately 20 minutes of | |||||||||||||||
| rest 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 |
.
3
| SUBJECT DEVICE:AM-7 | PREDICATE DEVICE:K030437 |
|---|---|
| NUNBER OF CHAMBERS | NUNBER OF CHAMBERS |
| 1 | 1 to 12, Varies with Garments |
| MATERIAL | MATERIAL |
| Operation Unit: ABS | |
| Massage Garment: Surface: Cotton / Polyester / | |
| Nylon | |
| Back: Velour | Operation Unit: ABS |
| Massage Garment: TPU | |
| Nylon with TPU Backing 190X70 with TPU | |
| Backing | |
| Pressure control | Pressure control |
| Microprocessor and Pressure Sensor | Microprocessor |
| Inflation | Inflation |
| Pressurization pump | |
| Deflation | Pressurization pump |
| Deflation | |
| Electronic control exhaust valve | exhaust valve |
| POWER SOURCE | POWER SOURCE |
| 2×1.5-Volt"AA" Alkali battery | |
| Consumption 2W | Main body:120V 60Hz |
| Consumption 26W | |
| AC Adapter:120V 60Hz | |
| Consumption 36W |
.
.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
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
5
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
6
Indications for Use
510(k) Number (if known): K071596
Device Name : Portable Air Massager putifino AM-7
Indications for Use:
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).
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)
R
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K071596