K Number

Device Name

THE ODFS DROPPED FOOT STIMULATOR

Manufacturer

DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG.

Date Cleared

2005-07-15

(87 days)

Product Code

GZI

Regulation Number

882.5810

Intended Use

The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the swing phase of gait, the ODFS electrically stimulates muscles in the leg and ankle of partially paralyzed individuals to provide flexion of the foot and may thus improve the individual's gait. Additional benefits of Functional Electrical Stimulation (FES) may include muscle re-education, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow. The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.

Device Description

The ODFS Dropped Foot Stimulator (ODFSIII Version 6.2) is an external functional neuromuscular stimulator. The ODFS Dropped Foot Stimulator electrically stimulates the common peroneal nerve which may produce contraction of the appropriate muscles that cause dorsiflexion of the ankle in individuals who have lost the ability to do so following neurological injury. The device is comprised of a small belt-worn, single-channel, foot-switch controlled stimulator used with skin-surface stimulating electrodes. The surface electrodes are typically placed over the common peroneal nerve as it passes near the head of the fibula and the motor point of the tibialis anterior in the lower leg. The heel switch allows the delivery of stimulation to be triggered according to the gait of the user.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K951951, K974514

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a functional electrical stimulator triggered by a heel switch based on gait, with no mention of adaptive algorithms, learning, or data processing beyond basic electrical stimulation control.

Therapeutic

Yes
The device is described as providing "adjunctive therapy for the treatment of dropped foot," and its intended use is to "provide ankle dorsiflexion" and "may thus improve the individual's gait," which aligns with the definition of a therapeutic device.

Diagnostic

Explanation: The device description states its purpose is to "electrically stimulates muscles in the leg and ankle... to provide flexion of the foot and may thus improve the individual's gait." It is a stimulator to improve function, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is comprised of a belt-worn stimulator, skin-surface electrodes, and a heel switch, which are all hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The ODFS Dropped Foot Stimulator is an external device that applies electrical stimulation to the leg and ankle to improve gait. It does not analyze samples taken from the body.
Intended Use: The intended use clearly describes a therapeutic function (providing ankle dorsiflexion) and potential benefits related to muscle function and blood flow, not diagnostic testing.
Device Description: The description details an external stimulator, electrodes, and a foot switch, all components of a therapeutic device, not an IVD.

Therefore, the ODFS Dropped Foot Stimulator is a therapeutic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.

Product codes (comma separated list FDA assigned to the subject device)

GZI and IPF

Device Description

The device is comprised of a small belt-worn, single-channel, foot-switch controlled stimulator used with skin-surface stimulating electrodes. The surface electrodes are typically placed over the common peroneal nerve as it passes near the head of the fibula and the motor point of the tibialis anterior in the lower leg. The heel switch allows the delivery of stimulation to be triggered according to the gait of the user.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

leg, ankle, common peroneal nerve, tibialis anterior, lower leg

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical supervision

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 ODFS system has been subjected to testing to verify that the device meets its key output specifications. All units tested met product specifications.

Testing included:

Functional verification testing of output and operational characteristics .
IEC 60601-1 (EN 60601-1:1988 with amendments of 1991 & 1995). .
IEC 60601-2-10 (as applicable). ●
ISO 60601-1-2 (as applicable). .

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.

K951951, K974514

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

Regulation Number and Section

§ 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).

Summary

K050991

JUL 1 5 2005

510(k) Summary For The ODFS Dropped Foot Stimulator

1. SPONSOR

Department of Medical Physics and Biomedical Engineering Salisbury Heath Care NHS Trust Salisbury District Hospital Salisbury Wiltshire SP2 8BJ United Kingdom

Tina E. Lechman, NDI Medical Contact Person: 216-378-9106 ext. 101 Telephone:

April 15, 2005 Date Prepared:

NDI Medical (US Agent) One Chagrin Highlands 2000 Auburn Drive, Suite 320 Cleveland, OH 44122 Telephone: 216-378-9106 Fax: 216-378-9116

Device Name 2.

Trade/Proprietary Name:	The ODFS Dropped Foot Stimulator
Common/Usual Name:	External Functional Neuromuscular Stimulator (FES)
Classification Name:	External Functional Neuromuscular Stimulator (FES)
Powered Muscle Stimulator (NMES)
Classification Code:	Class II
Product Codes:	GZI and IPF

3. PREDICATE DEVICES

Predicate Name	Company	K Number
EMPI Focus Model 795	EMPI	K951951
WalkAide	NeuroMotion	K974514

DEVICE DESCRIPTION 4.

ട. INTENDED USE

Feature	ODFS	EMPI Focus Model 795	WalkAide
Waveform	Biphasic
(Symmetrical and
Balanced Asymmetrical)	Biphasic
(Symmetrical and
Balanced Asymmetrical)	Not available
Pulse Width	7 (±4) to 365(±20) µsec
(patient selectable)	300 µsec	200 µsec
Frequency (Hz)	40 (±4) Hz	25, 30, 35, 45, 50, 80 Hz	25 Hz
Indications for Use	To provide ankle
dorsiflexion in individuals
with dropped foot following
an upper motor neuron
injury. During the swing
phase of gait, the ODFS
electrically stimulates
muscles in the leg and ankle
of partially paralyzed
individuals to provide
flexion of the foot and may
thus improve the individual's
gait. Additional benefits of
Functional Electrical
Stimulation (FES) may
include muscle re-education,
prevention/retardation of
disuse atrophy, maintained
or increased joint range of
motion, and increased local
blood flow.	As a TENS device:
Symptomatic relief and management
of chronic intractable pain;
adjunctive treatment for post-
surgical and post-trauma acute pain
As a NMS/NMES device:.
Relaxation of muscle spasm;
prevention or retardation of disuse
atrophy; increasing local blood
circulation; muscle re-education;
immediate post-surgical stimulation
of the calf muscles to prevent
venous thrombosis; maintaining or
increasing range of motion.
As a FES device:
Stimulating muscles in the leg and
ankle of partially paralyzed patients
to provide flexion of the foot and
thus improve the patient's gait.	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 FES
may include
prevention/retardation of
disuse atrophy, increased
local blood flow, muscle
re-education, and
maintained or increased
joint range of motion.
Accessories	Heel switch	Heel switch, Hand switch	Heel switch, Tilt sensor
Electrode Size and
Shape	5.0 cm x5.0cm square = 25 cm2
4cm x 6.4 cm oval = 20 cm2	5.1cm2	2.5cm round

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

7. PERFORMANCE TESTING

The ODFS system has been subjected to testing to verify that the device meets its key output specifications. All units tested met product specifications.

Testing included:

Functional verification testing of output and operational characteristics .
IEC 60601-1 (EN 60601-1:1988 with amendments of 1991 & 1995). .
IEC 60601-2-10 (as applicable). ●
ISO 60601-1-2 (as applicable). .

Based on the information provided, the ODFS Dropped Foot System is substantially equivalent to legally marketed predicate devices.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Department of Medical Physics and Biomedical Eng. Salisbury Health Care NHS Trust c/o Ms. Tina E. Lechman Clinical Project Manager, US Agent NDI Medical One Chagrin Highlands 2000 Auburn Drive, Suite 320 Cleveland, Ohio 44122

JUL 1 5 2005

Re: K050991

Trade/Device Name: ODFS Dropped Foot Stimulator Regulation Number: 21 CF 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: II Product Code: GZI Dated: July 8, 2005 Received: July 11, 2005

Dear Ms. Lechman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarer of the device is substantially equivalent (for the indications felerenced above and nave develomined by marketed predicate devices marketed in interstate for use stated in the enorosure) (3 16gars) in the Medical Device Amendments, or to commerce prior to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices mat nave occh rechasined in assere approval of a premarket approval application (PMA). alle Costile Act (110.) that to hovice, subject to the general controls provisions of the Act. The r ou may, mercere, mainer of the Act include requirements for annual registration, listing of general controlly provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassined (too as corrols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of actived that it is mination that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must or any I each statutes and streequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quant) by by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Ms. Tina E. Lechman

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieming your and equivalence of your device to a legally premarket notheadon: "The PDF milling of east will be 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), please If you desire specific advice for your accept 2011 276-0120. Also, please note the regulation entitled, program and Colliact the Orition of Compilance and (21CFR Part 807.97). You may obtain Misofanung by reference to premainentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Signature

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K050991

Device Name: ODFS Dropped Foot Stimulator

Indications for Use:

The ODFS Dropped Foot Stimulator is intended to provide ankle dorsiflexion in individuals with dropped foot following an upper motor neuron injury. During the morradaze with the ODFS electrically stimulates muscles in the leg and ankle of swing prace or grouped individuals to provide flexion of the foot and may thus improve partially paral's gait. Additional benefits of Functional Electrical Stimulation (FES) the marriadal s garrestion, prevention/retardation of disuse atrophy, maintained or increased joint range of motion, and increased local blood flow.

The ODFS is a medical device and should only be used under medical supervision for adjunctive therapy for the treatment of dropped foot following an upper motor neuron injury.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

19131011 Sign-Off) Ivision of General, Restorative and Neurological Devices

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