(248 days)
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).
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 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.
§ 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).