(90 days)
Not Found
No
The device description details a pneumatic system with a pump, valves, and pressure sensor for sequential inflation. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML technology in medical devices.
Yes
The device is intended for temporary increase in local blood circulation and temporary relief of minor muscle aches and pains in the lower extremities, which are therapeutic indications.
No
The device description and intended use do not mention any diagnostic capabilities. Its purpose is to provide therapeutic sequential foot compression.
No
The device description explicitly states it includes hardware components such as a pneumatic unit with a pump, valves, pressure sensor, tubing, and inflatable sandals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LiteWalk is for "temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied." This describes a therapeutic or physical therapy device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a pneumatic compression device that applies pressure to the feet. This mechanism of action is physical and external, not related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any of the typical components or processes associated with IVD devices.
Therefore, the LiteWalk is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The LiteWalk is intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
The LiteWalk is a pneumatic sequential foot compression device, designed primarily for temporary improvement in blood flow circulation in the lower limb. The system is based on a pneumatic unit that includes a pump, valves, pressure sensor and tubing, and is fed by an external power supply of 12V DC.
The unit is connected through 2 sets of 4-tubes to 2 inflatable sandals. Each sandal has 4 inflatable pressure chambers, located to match the foot anatomy: heel, arch, metatarsals, and toes. The sandals come in a pair, for right and left feet, and in 3 sizes: small, medium, large. The operation is based on sequential inflation of the 4 chambers, from heel to toes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower extremities (foot)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and hospital use
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)
The LiteWalk device have been thoroughly tested through verification of specifications and validation, including software validation.
No clinical study was conducted to support this application.
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.
PPCID, K000655
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
December 23, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. The HHS logo is a symbol of an eagle.
Viasonix Ltd. Dan Manor CEO 10 Hamelacha Street Raananna, IL 4366105
Re: K192607 Trade/Device Name: LiteWalk Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: September 16, 2019 Received: September 20, 2019
Dear Dan Manor:
This letter corrects our substantially equivalent letter of December 19, 2019.
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather L. Dean -S
for: Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192607
Device Name LiteWalk
Indications for Use (Describe)
The LiteWalk is intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied .
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SECTION 5 - 510(K) SUMMARY
5.1 ADMINISTRATIVE INFORMATION
| Date: | 10-September-2019 |
|---|---|
| Submitter: | Viasonix Ltd. |
| 10 Hamelacha Street | |
| Raanana , ISRAEL 4366105 | |
| Phone : 972-9-7441692 | |
| Official Correspondent: | Dan Manor, CEO |
| Trade Name: | LiteWalk |
| Classification Name: | |
| Classification Number: | Powered inflatable tube massager |
| 21 CFR 890.5650 | |
| Product Code: | |
| Device Class: | IRP |
| Class II | |
| Predicate Devices: | PPCID, K000655 |
5.2 Device Description
The LiteWalk is a pneumatic sequential foot compression device, designed primarily for temporary improvement in blood flow circulation in the lower limb. The system is based on a pneumatic unit that includes a pump, valves, pressure sensor and tubing, and is fed by an external power supply of 12V DC.
The unit is connected through 2 sets of 4-tubes to 2 inflatable sandals. Each sandal has 4 inflatable pressure chambers, located to match the foot anatomy: heel, arch, metatarsals, and toes. The sandals come in a pair, for right and left feet, and in 3 sizes: small, medium, large. The operation is based on sequential inflation of the 4 chambers, from heel to toes.
5.3 Intended Use and Indications for Use
The LiteWalk is Intended for home and hospital use for temporary increase in local blood circulation in the lower extremities and temporary relief of minor muscle aches and pains where applied
4
5.4 CONTRAINDICATIONS
The LiteWalk is not intended for use if any of the following medical conditions exist. Consult with a physician whenever there is doubt whether it is clinically safe to use the LiteWalk.
• Presumptive evidence of congestive heart failure where increase in blood returned to the heart could be detrimental
- Pre-existing deep vein thrombosis (DVT) or blood clots
- Existing hemorrhagic disease or coagulation problems
- Thrombophlebitis
- Pulmonary embolism
5.5 Summary of Technical Characteristics
The LiteWalk device is similar to the predicate device cited above [section 5.1] intended for powered inflatable tube massager applications.
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, the intended use, use environment and target patient population of the LiteWalk device is substantially equivalent to the predicate device cited above.
5
5.5.1 Summary table of Comparison
| Specification | LiteWalk | PPCID | Differences discussion |
|---|---|---|---|
| 510(k) number | Proposed Device | K000655 | NA |
| Manufacturer | VIASONIX LTD. | Medical Dynamics LLC | NA |
| Product Regulation | 21CFR890.5650 - Powered | ||
| inflatable tube massager | 21CFR890.5650 - Powered | ||
| inflatable tube massager | Identical | ||
| Product Code | IRP - Powered inflatable tube | ||
| massager | IRP - Powered inflatable tube | ||
| massager | Identical | ||
| Indications for use | Intended for home and | ||
| hospital use for temporary | |||
| increase in local blood | |||
| circulation in the lower | |||
| extremities and temporary | |||
| relief of minor muscle aches | |||
| and pains where applied | Intended for home and | ||
| hospital use for temporary | |||
| increase in local blood | |||
| circulation in the lower | |||
| extremities and temporary | |||
| relief of minor muscle aches | |||
| and pains where applied | Identical | ||
| Contraindications | Use of the LiteWalk is | ||
| contraindicated in patients | |||
| for whom: | |||
| • Presumptive evidence of | |||
| congestive heart failure | |||
| where increase in blood | |||
| returned to the heart | |||
| could be detrimental | |||
| • Pre-existing deep vein | |||
| thrombosis (DVT) or | |||
| blood clots | |||
| • Existing hemorrhagic | |||
| disease or coagulation | |||
| problems | |||
| • Thrombophlebitis | |||
| • Pulmonary embolism | Use of the PPCID is | ||
| contraindicated in patients for | |||
| whom an increase in | |||
| blood returned to the heart | |||
| could be detrimental, | |||
| including those with | |||
| presumptive evidence of | |||
| congestive heart failure, pre- | |||
| existing deep vein thrombosis, | |||
| thrombophelbitis, existing | |||
| hemorrhagic disease, | |||
| coagulation problems, or | |||
| pulmonary embolism | Identical | ||
| Environment | |||
| of Use | Hospital and Home care | Hospital and Home care | Identical |
| Rx OR OTC | OTC | OTC | Identical |
| Mode of | |||
| compression | Sequential | Sequential | |
| *Not publicly available | Similar to the predicate | ||
| Use Time [min] | Recommended 30 min | 30 min or more | |
| *Not publicly available | Similar to the predicate | ||
| Sequential cycles | |||
| time | 2-3 cycles per minute | 2-3 cycles per minute | |
| *Not publicly available | Similar to the predicate | ||
| Modes | 1 mode : Sequential | ||
| inflation/deflation of 4 | |||
| chambers from heel to toes | 1 mode : Sequential | ||
| inflation/deflation of 4 | |||
| chambers from heel to toes | |||
| *Not publicly available | Similar to the predicate | ||
| Specification | LiteWalk | PPCID | Differences discussion |
| Max Pressure | 160 mmHg | 80-200 mmHg | |
| *Not publicly available | Similar to the predicate. | ||
| Within the predicate pressure range | |||
| Types of Garments | Foot Sandal | Foot Sandal | |
| *Not publicly available | Similar to the predicate. | ||
| Foot Sandal type is supported by the | |||
| predicate device | |||
| Garment sizes | 3 sizes: small, medium, large | 3 sizes: small, medium, large | |
| *Not publicly available | Similar to the predicate | ||
| Patient contact | |||
| materials | Polyester [PVB0123, Colored | ||
| Fabric] | Not known | ||
| *Not publicly available | Similar to the predicate. | ||
| Both sharing a fabric for the Sandals. | |||
| LiteWalk Polyester skin contact material | |||
| comply with ISO 10993 | |||
| Patient contact | Non conductive | Non conductive | |
| *Not publicly available | Similar to the predicate | ||
| Number of chambers | 4 | 4 | |
| *Not publicly available | Similar to the predicate | ||
| Line Voltage / | |||
| Frequency | 100-240 Vac / 50-60Hz | ||
| 12V , 2.0A | 115 Vac / 60 Hz, 7W | ||
| *Not publicly available | Similar to the predicate | ||
| Power Consumption | 8 W | 7W | |
| *Not publicly available | Similar to the predicate | ||
| Safety feature | Power button on main unit | ||
| allows user to stop therapy | |||
| session at any time. | Power button on main unit | ||
| allows user to stop therapy | |||
| session at any time. | |||
| *Not publicly available | Similar to the predicate | ||
| User Interface | No | No | |
| *Not publicly available | Similar to the predicate | ||
| Indicator | Green led | Led | |
| *Not publicly available | Similar to the predicate | ||
| Technology | Compressor and valve system | ||
| which sequentially inflates | |||
| inflatable chambers | Compressor and air distributor | ||
| system which sequentially | |||
| inflates inflatable chambers | |||
| *Not publicly available | Both sharing the same functionality. | ||
| The valve allows better control over | |||
| inflation and allows quick deflation. | |||
| This slight change doesn't impact | |||
| product safety and performance. | |||
| Standards | IEC 60601-1 | ||
| IEC60601-1-2 | |||
| IEC60601-1-11 | |||
| ISO 10993-1 | IEC 60601-1 | ||
| IEC60601-1-2 | |||
| ISO 10993-1 | |||
| *Not publicly available | Similar to the predicate. | ||
| The LiteWalk meets all latest standards | |||
| edition |
6
7
5.6 UTILIZATION OF STANDARDS AND GUIDANCE'S:
The LiteWalk meets the following standards:
-
- IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
- IEC 60601-1-11: 2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
-
- IEC 62366-1: 2015 Medical devices Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
-
- IEC 60601-1-6: 2013 [Edition 3.1] Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
8
5.7 Summary of Non-Clinical Performance Testing
Summary of Non-Clinical Tests:
The LiteWalk device have been thoroughly tested through verification of specifications and validation, including software validation.
5.8 Summary of Clinical Performance Data
No clinical study was conducted to support this application.
5.9 Conclusions
Based on its underlying technology and bench tests performed, the LiteWalk is substantially equivalent to the predicate device.