(251 days)
Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.
Air Pressure Therapy System is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. 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.
Air Pressure Therapy System, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve the circulation of blood.
The provided FDA 510(k) summary (K201982) indicates that the Air compression therapy system FO-3001 and FO-3008 are substantially equivalent to the NormaTec Pulse and NormaTec Pulse Pro (K160608) predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, quantified list with pass/fail thresholds. Instead, the substantial equivalence is established by comparing the subject device's characteristics against those of the predicate device (K160608). The underlying assumption is that if the subject device's performance, safety features, technological characteristics, and intended use are similar or equivalent to a legally marketed predicate, it meets the necessary criteria for market clearance.
The "acceptance criteria" are implicitly derived from the characteristics of the predicate device and the recognized consensus standards. The "reported device performance" is then the subject device's characteristics as described.
| Characteristic | Acceptance Criteria (Predicate Device K160608) | Reported Device Performance (FO-3001/FO-3008) | Discussion of Differences |
|---|---|---|---|
| Indications for Use | Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in treated areas. | Same |
| Rx or OTC | OTC | OTC | Same |
| Pressure Range | 30-110mmHg | 30-110mmHg | Same |
| Treatment Time | Stays on until the user turns it off, or can be set up to turn off in a range of 10 mins to continuous / User controlled 10 minutes to 175 minutes or continuous – total time over 4 segments. | 1-60mins | Similar: Subject device's treatment time is smaller. Concluded not to adversely impact safety and effectiveness. |
| Standards Applied | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | IEC 60601-1-11:2015, IEC 60601-1-2:2014, IEC 60601-1:2005, ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-12:2012 | Similar: Both devices adhere to relevant electrical safety, EMC, and biological evaluation standards. The subject device lists additional ISO standards for biological evaluation. |
| Mode of Compression | Sequential Gradient, Peristaltic and Pulsing | Sequential (FO-3001 has 6 modes including "Normal Mode" which is sequential; FO-3008 has 4 modes including "Normal Mode" which is sequential) | Same (regarding sequential): While the subject device offers more "work modes" (e.g., Double Wave, Whole Squeeze, Combined modes), the "Mode A (Normal Mode)" for both FO-3001 and FO-3008 aligns with the predicate's sequential compression. The differences in other modes and chamber inflation order are argued not to adversely impact safety and effectiveness due to the same pressure range. |
| Power Source | 12 VDC via an IEC 60601-1 compliant power supply (100-240 VAC input) Optional Integrated rechargeable battery | 100-127V/220-240V, 50/60Hz | Similar: Both use standard power supplies. Differences are in specific voltage/Hz and the predicate's optional battery. Concluded as similar. |
| Power Consumption | 14W | 65W | Similar: Different wattage, but implies it's not a safety/effectiveness concern. |
| Safety Feature | Button on display allows user to stop or pause therapy session at any time | Power button on main unit allows user to stop therapy session at any time | Same |
| Technology | Compressor and valve system which sequentially inflates inflatable chambers | Compressor and valve system which sequentially inflates inflatable Chambers | Same |
| Dimensions | 4" x 5" x 9" | FO-3001: 220190113MM; FO-3008: 240200110MM | Similar: Different physical dimensions. |
| Number of Chambers | 5 or less | FO-3001: 4, 6, 8 Chambers for each unit; FO-3008: 4 Chambers for each unit | Similar: FO-3001 offers more chambers. This difference is not stated to adversely impact safety and effectiveness. |
| Housing Materials | Molded ABS enclosure | Molded ABS enclosure | Same |
2. Sample size used for the test set and the data provenance
The document states "Performance Testing - Clinical: Not Applicable" and "Performance Testing - Animal: Not Applicable" (Page 4). This indicates that no clinical or animal studies were conducted for this 510(k) submission to demonstrate performance. The clearance is based on substantial equivalence to the predicate device through technological comparison and adherence to recognized consensus standards.
Therefore, there is no test set, sample size, or data provenance information provided in this document as it was not required for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical or animal performance testing was conducted, there was no test set, and therefore no experts were used to establish ground truth in the context of device performance. The evaluation was primarily engineering and regulatory.
4. Adjudication method for the test set
Not applicable, as no dedicated test set or clinical performance study was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an air compression therapy system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is hardware-based for physical therapy, not an algorithm or software. No standalone performance study was conducted.
7. The type of ground truth used
Not applicable, as no performance studies with a ground truth component were conducted. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the legally marketed predicate device (K160608), supported by the subject device's adherence to relevant technical standards.
8. The sample size for the training set
Not applicable, as this device does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established
Not applicable, as this device does not involve machine learning or AI models with training sets.
§ 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).