(67 days)
Not Found
No
The summary describes a functional electrical stimulator that uses a foot sensor or tilt sensor to trigger stimulation during the gait cycle. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to address a medical condition (lack of ankle dorsiflexion due to neurological damage) and provides therapeutic benefits such as stimulating muscles, improving gait, preventing disuse atrophy, and maintaining joint range of motion.
No
Explanation: The device is described as an external functional electrical stimulator intended to address lack of ankle dorsiflexion by electrically stimulating muscles. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is an "external functional electrical stimulator" and "a small device that attaches to the leg," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the NeuroMotion WalkAide is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- WalkAide Function: The WalkAide is an external device that applies electrical stimulation to the leg to improve gait. It interacts directly with the patient's body and does not analyze any biological samples.
- Intended Use: The intended use clearly describes a therapeutic function (addressing lack of ankle dorsiflexion) and potential medical benefits related to muscle function and blood flow, not diagnostic testing of samples.
- Device Description: The description focuses on the physical device and its mechanism of action (electrical stimulation of a nerve), not on sample analysis.
Therefore, the WalkAide falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroMotion WalkAide is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
Product codes
GZI, IPF
Device Description
The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.
Users of the WalkAide are people who have lost the ability to voluntarily lift their foot by flexing the ankle, often as a result of damage to the central nervous system such as stroke, spinal cord injury, and traumatic brain injury. This stimulation will not work with people who have damage to the lower motor neurons/peripheral nerves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg just below the knee, near the head of the fibula
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
The following tests were conducted to aid in the determination of substantial equivalence, and successfully completed:
- Stimulation Pulse Characteristics .
- Electrode Current Density Spread ●
- . Foot Sensor Characteristics
- . Stimulation Trigger Source Timing Foot Sensor Tilt Sensor
- Clinician System Application Program ●
Key Metrics
Not Found
Predicate Device(s)
K920436, K903434C, K800380A, K813515
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
0
NEUROMotionFEB - 6
401 11044 - 82 AVENUE EDMONTON, ALBERTA CANADA T6G OT2
PHONE: (403) 433-1700 FAX: (403) 433-2893
510(K) SUMMARY
GENERAL
SUBMITTOR:
NeuroMotion Inc.
401 11044 - 82 Avenue NW Edmonton, Alberta Canada T6G 0T2
Phone (403) 433-1700 (403) 433-2893 Fax
Contact: Brian Zerb, Director of Quality
DATE PREPARED:
98-01-27
DEVICE:
| Proprietary Name - | WalkAide |
|---|---|
| Common/Usual Name - | External Functional Neuromuscular Stimulator |
| Classification Name - | External Functional Neuromuscular Stimulator |
| Classification Code - | Class II |
PREDICATE DEVICES:
| Medtronic, Inc. | Respond III | K920436 |
|---|---|---|
| Medtronic, Inc. | Respond Select® | K903434C |
| Empi, Inc. | Model 2000 | K800380A |
| Verite | Model 817 VERI/DFS™ | K813515 |
510(K) SUMMARY - WALKAIDE - K974514
1
DEVICE DESCRIPTION:
The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.
Users of the WalkAide are people who have lost the ability to voluntarily lift their foot by flexing the ankle, often as a result of damage to the central nervous system such as stroke, spinal cord injury, and traumatic brain injury. This stimulation will not work with people who have damage to the lower motor neurons/peripheral nerves.
INTENDED USE:
The NeuroMotion WalkAide is intended to address the lack of ankle dorsifiexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
| Feature | WalkAide | Marketed
Devices | | |
|-------------------------------------------|----------------------------|---------------------------------------------------|--------------------------------|---------------------------------|
| Device Name | WalkAide | Respond III and
Respond Select® | EMPI
Model 2000 | Verite Model
817
VERI/DFS |
| Constant Current
Range (1000 Ohm load) | 0 - 95mA | 0 - 100mA | | 0 - 50 mA |
| Pulse Duration (μsec.) | 200 | 300 | + ve: 500 | 110 |
| Frequency Range
(PPS) | 25 | 1 - 80 | 20 - 50 | 50 |
| Electrode Size and
Shape | 2.5cm
diameter
Round | Various, including
SnapEase®
2.5cm diameter | 3cm & 5cm
diameter
Round | 4.3cm diameter
Round |
COMPARISON TABLE
2
DISCUSSION OF SUBSTANTIAL EQUIVALENCE:
STIMULATION CHARACTERISTICS
Pulse shape, pulse width, pulse intensity, and pulse repetition frequency are substantially equivalent to the predicate devices.
STIMULATION ACTIVATION TRIGGER MECHANISM
Beside being capable of using a foot sensor to trigger stimulation, the WalkAide mainly utilizes a built-in tilt sensor to trigger stimulation on and off points in an equivalent manner to a foot sensor.
ELECTRODES
The WalkAide electrodes are similar to certain electrodes listed with the predicate devices. They are 2.5cm in diameter, contain an integral snap connector, and are pre-gelled.
TESTING:
The following tests were conducted to aid in the determination of substantial equivalence, and successfully completed:
- Stimulation Pulse Characteristics .
- Electrode Current Density Spread ●
- . Foot Sensor Characteristics
- . Stimulation Trigger Source Timing Foot Sensor Tilt Sensor
- Clinician System Application Program ●
CONCLUSION:
Based on the information provided above, NeuroMotion believes that the WalkAide is substantially equivalent to the existing legally marketed devices, and does not alter or introduce any issues regarding safety and effectiveness.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 1998
Mr. Brian Zerb · Director of Quality NeuroMotion, Inc. 401 11044-82 Avenue Edmonton, Alberta Canada T6G 0T2
K974514 Re: WalkAide Requlatory Class: II Product Codes: GZI and IPF November 27, 1997 Dated: December 1, 1997 Received:
Dear Mr. Zerb:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. . A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Brian Zerb
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K974514
WalkAide Device Name:
Indications for Use:
The NeuroMotion WalkAide is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gair. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased. local blood flow, muscle re-education, and maintained or increased joint range of motion.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcole &
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974514
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter
510(K) NOTIFICATION - WALKAIDE DATE PREPARED: 97-11-27 REVISION DATE: 98-01-27