FOOT WEIGHT ALARM

K962591 · Cleveland Medical Devices, Inc. · IRN · Dec 4, 1996 · Physical Medicine

Device Facts

• Record ID: K962591
• Device Name: FOOT WEIGHT ALARM
• Applicant: Cleveland Medical Devices, Inc.
• Product Code: IRN · Physical Medicine
• Decision Date: Dec 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern.

Device Story

Foot-shaped insole device fits inside patient shoe; monitors weight distribution on limited weight-bearing foot. System includes insole, shoe pouch, foot unit, and data cable. Healthcare professional uses calibration system to program force thresholds. Device provides audible alarm to patient when weight exceeds or falls below programmed limits. Used for gait training in orthopedic/neurological rehabilitation. Benefits include facilitating return to normal gait patterns through real-time feedback.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate device.

Technological Characteristics

Insole-based pressure measurement system. Sensors: load sensors located under heel and toes. Output: audible alarm. Dimensions: 9.5 x 6.0 x 2.5 cm. Powered external limb overload warning device.

Indications for Use

Indicated for patients with orthopedic and neurological disabilities, including malunion fracture, amputation, and cerebral vascular accident, requiring weight-bearing training to limit or reach specific force levels on a leg.

Regulatory Classification

Identification

A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• BarMed Pty. Ltd. Portable Limb Load Monitor BMLLM-100 (K915326)

Submission Summary (Full Text)

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Cleveland Medical Devices Inc.™ K962591

11000 CEDAR AVENUE • SUITE 439 • CLEVELAND, OHIO 44106 • PHONE: [phone] • FAX: [phone]

# 510(K) SUMMARY

A) Submitter's Name: Cleveland Medical Devices Inc. DEC - 4 1996
B) Address: 11000 Cedar Ave. Suite 439
Cleveland, Ohio 44106
C) Phone and Fax numbers: Phone: [phone] Fax: [phone]
D) Contact Person: Tracie L. Lawrence
E) Preparation Date: June 26, 1996
F) Classification Name: Powered external limb overload warning device

Common / Usual Name: Pressure Measurement System

Proprietary Name: Foot Weight Alarm

Classification: Class II The classification number for this device is 89 IRN and is reviewed by the Physical Medicine Panel.

Regulation: 890.5575 A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.

G) Substantial Equivalence: The design concept of the Foot Weight Alarm is substantially equivalent in design to the BarMed Pty. Ltd. Portable Limb Load Monitor BMLLM-100
BarMed Pty. Ltd. Portable Limb Load Monitor BMLLM-100 K915 326
H) Description: The Foot Weight Alarm is a foot shaped insole device to fit inside the patient's shoe to warn the patient when they are putting too little or too much weight on a limited weight bearing foot. It consists of an Insole, a Shoe Pouch which laces to the shoe, a foot unit which fits in the Shoe Pouch and connects to the Insole, a data cable that is used by a health care professional to program the Foot Weight Alarm unit; and Foot Weight Alarm Calibration System used by the health care professional to program the Foot Unit.

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Cleveland Medical Devices Inc.

11000 CEDAR AVENUE • SUITE 439 • CLEVELAND, OHIO 44106 • PHONE: [phone] • FAX: [phone]

I) Intended Use: The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern.

J) Summary of Safety and Effectiveness Foot Weight Alarm: The Summary of Safety and Effectiveness on Foot Weight Alarm used reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

The Foot Weight Alarm is similar in application and operation to the BarMed LLM-100 of Barmed Pty. Ltd.

| | Foot Weight Alarm | BarMed LLM-100 |
| --- | --- | --- |
| Sensors: | load sensors placed under heel and toes | load sensors placed under heel and toes |
| Alarm: | Audible | Audible |
| Portable: | Yes | Yes |
| Monitor Dimension: | 9.5 x 6.0W x 2.5 cm | 13 x 6W x 3 cm |

The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of our Foot Weight Alarm is comparable to that of the other monitor.