Search Results
Found 1 results
510(k) Data Aggregation
(171 days)
NeoWave Pain Relief and Recovery System, Model# T16-2020
The NeoWave Pain Relief and Recovery System is indicated for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels.
The NeoWave Pain Relief and Recovery System Model # T16-2020 is a reusable, nonsterile therapy device intended to provide a gentle, rhythmic, soothing sensation using timed, pre-programed air pressure to inflate and deflate air channels within the therapy attachments. Each air channel inflates then deflates one at a time, to simulate the press and release action of the human hand by manipulating the soft tissues of the body relieving pain and increasing circulation. This device is a gradient, sequential, pneumatic compression device intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. The NeoWave Pain Relief and Recovery System simulates the kneading and stroking of tissues by using inflatable air channels. The NeoWave Pain Relief and Recovery System consists of an air compressor, valve module(s) and a therapy attachment working together as one unit. The therapy attachments contain one or two valve modules that connect to the Controller Unit via a series of receptacles, tubing, and cabling. The system uses an external power supply of 12V DC. The Therapy Attachments/Cushions consist of inflatable welded pads with 8 or 16 air channels. The massage direction is distal to proximal (toward the heart). The sequential inflation cycle inflates then deflates one air channel at a time, for 3, 4 or 5 seconds allowing the user/patient to adjust the pressure. The therapy attachment/cushion works under the action of the valve module sensor and microprocessor.
This document outlines the acceptance criteria and study information for the NeoWave Pain Relief and Recovery System based on the provided text.
Acceptance Criteria and Reported Device Performance
No specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) were provided in the document. The substantial equivalence determination is primarily based on performance in general safety, electrical safety, EMC, biocompatibility, packaging, software verification, mechanical bench testing, and usability in comparison to a predicate device.
The table below summarizes the technical comparison provided in the document.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Comparison |
|---|---|---|---|
| General | |||
| Manufacturer | SALTON, INC. | EVA MEDTEC, INC. | N/A (Different companies) |
| 510(K) Number | K030437 | K202693 | N/A (Different K-numbers) |
| Model Name | Relaxor Perfect Touch Air Massaging System | NeoWave System T16-2020 | N/A (Different names) |
| Classification | Class II Device, IRP (21 CFR890.5650) | Class II Device, IRP (21 CFR890.5650) | Same |
| Indications for Use | Temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. Simulates kneading and stroking of tissues by using an inflatable garment. | Temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health. Simulates kneading and stroking of tissues by using inflatable air channels. | Same |
| OTC or Rx | OTC | OTC | Same |
| Environment Of Use | Home environment | Home or clinical environment | Same (Includes home, extends to clinical) |
| Principle of Operation | Sequential pneumatic compression | Sequential pneumatic compression | Same |
| Power Source | 120V, 60Hz | 120V, 60Hz (External power supply of 12V DC mentioned for controller unit, but ultimate source usually 120V in US) | Same (Assuming the 12V DC is from an adapter connected to 120V) |
| Sterility of the Device | Not specified but implied non-sterile for this type of device. | Non-Sterile | Same (Explicitly stated for subject device) |
| Reusable Life | Not specified but implied Multi Use. | Multi Use | Same (Explicitly stated for subject device) |
| SW/Firmware/Microprocessor Control | Microprocessor | Microprocessor | Same |
| Technology | Compressor and valve system which sequentially inflate air channels of the appliance/therapy attachment | Compressor and valve system which sequentially inflate air channels of the appliance/therapy attachment | Same |
| Physical/Operational Characteristics | |||
| Therapy Time | Has 15-minute sessions, up to 30 minutes in one session, can be used up to twice daily for 60 minutes. | Has 15- or 30-minute sessions, up to 30 minutes in one session, can be used up to twice daily for 60 minutes. | Same |
| Number of Chambers | 12 chambers | 16 Chambers – Neck/Back Cushion; 8 Chambers – Lumbar Cushion | Minor difference (Subject device has more chambers in one configuration) |
| Compression Applicator/Cushion/Garment Material | Nylon with a polyurethane laminate | Compression applicator (inflatable air channels inside the therapy attachments): Nylon with a Polyurethane laminate. Outer therapy attachment cover material: 72% Polyester, 6% spandex microfleece, 28% PU film. | Similar (Similar core material, subject device has an additional outer cover) |
| Power Consumption | 26W | 30W | Similar (Slightly higher power consumption for subject device) |
| Cycle Time (per chamber) | Range of 15 sec to 1 min 5 sec | 3 sec, 4 sec or 5 sec per chamber; Range of 24 sec to 1 min 20 sec (for an entire cycle, not per chamber) | Similar (Cycle time range slightly different, but overall similar function) |
| Size | 9" x 6" x 6" | 8.5" x 4.25" x 7.25" | Similar (Slightly different dimensions) |
| Weight | 3.2 pounds | 3 pounds | Similar (Marginal difference) |
| Housing Materials and Construction | Molded ABS enclosure | Molded ABS/PC enclosure | Similar (ABS/PC is a common variant of ABS) |
| Min & Max Inflation Pressure | Intermittent 80 to 200 mm Hg, 6 intensity settings (1 – 80 mm Hg, 2 – 104 mmHg, 3 – 128 mm Hg, 4 - 152 mm Hg, 5 – 176 mmHg, 6 - 200 mmHg) | Intermittent 113 to 149 mm Hg, 3 Pressure Levels (Mild - 113-144 mm Hg, Medium – 127-147 mm Hg, Intense – 134-149 mm Hg) | Similar (Subject device pressures are within the range of the predicate) |
| Modes (Inflation sequences, pre-programmed) | Not explicitly detailed, but implied sequential inflation. | 1 Mode: inflates and deflates chambers from bottom up (distal to proximal chambers). One at a time. | Similar (Both use sequential inflation) |
| Safety Features | Not explicitly detailed, but expected to have basic safety features common to such devices. | Button on the display allows user to stop or pause therapy session at any time. | Same (Fundamental safety feature) |
| Patient Contact | Not specified, but implied non-conductive. | Non-conductive attachments | Same (Explicitly stated for subject device) |
| Standards | Not available (for predicate) | IEC 60601-1: 2005, IEC 60601-1-2: 2014, IEC 60601-1-11: 2015, IEC 60601-1-6:2010, ISO 10993-10: 2010, ISO 10993-5: 2009 | Same, Meets consensus standards for ES, EMC & Biocompatibility (for subject device) |
Study Information
This document does not describe a clinical study comparing diagnostic accuracy or clinical outcomes. Instead, it relies on a series of non-clinical performance tests and comparisons to a predicate device to establish substantial equivalence.
- Sample size used for the test set and the data provenance: Not applicable. The studies conducted are non-clinical (electrical safety, EMC, biocompatibility, software verification, mechanical bench testing, usability). These tests are typically performed on samples of the manufactured device and its components, not on patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance is established by compliance with engineering standards and design requirements, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no diagnostic test set requiring expert adjudication.
- 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 physical therapy device (massager), not an AI-assisted diagnostic or assistive device for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical studies conducted:
- Electrical safety and EMC: Compliance with international standards (IEC 60601-1, IEC 60601-1-2) defines the "ground truth."
- Biocompatibility testing: Compliance with international standards (ISO 10993-1, ISO 10993-5, ISO 10993-10) defines the "ground truth."
- Shipping/Packaging Testing: Compliance with ASTM D4169-16 defines the "ground truth."
- Software Verification and Validation Testing: Compliance with FDA guidance for software in medical devices and internal design requirements defines the "ground truth."
- Mechanical Bench Testing: Meeting the system's Device Design Requirements defines the "ground truth."
- Usability Testing: Meeting predefined usability requirements and adequate mitigation of usability risks, in compliance with IEC 60601-1-6, defines the "ground truth."
- The sample size for the training set: Not applicable. As a medical device that performs mechanical action, it doesn't involve machine learning or AI models that require training data.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1