(155 days)
K915, K326
K915 326
No
The description focuses on a simple weight-sensing and alarm system, with no mention of AI/ML terms or complex data processing beyond calibration and programming.
Yes
The device is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, which aligns with the definition of a therapeutic device. It "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."
No
The device is described as a training aid for weight bearing, not for diagnosing medical conditions. It helps patients limit or reach a set amount of force on their leg.
No
The device description explicitly lists hardware components such as an Insole, Shoe Pouch, foot unit, data cable, and a Foot Weight Alarm Calibration System.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Foot Weight Alarm Function: The Foot Weight Alarm is a device that measures and provides feedback on the mechanical force applied to a patient's foot during weight-bearing activities. It does not analyze any biological specimens from the body.
- Intended Use: The intended use is for training and rehabilitation related to weight bearing, not for diagnosing or monitoring a disease or condition through the analysis of biological samples.
The device is a therapeutic and monitoring device used in a rehabilitation context, not an in vitro diagnostic device.
N/A
Intended Use / 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,
Product codes
IRN
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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 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. 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.
Key Metrics (Sensitivity,Specificity,PPV,NPV, etc.)
Not Found
Predicate Device(s)
K915 326
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5575 Powered external limb overload warning device.
(a)
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.(b)
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.
0
Cleveland Medical Devices Inc.™
11000 CEDAR AVENUE · SUITE 439 · CLEVELAND, OHIO · PHONE: (216) 791-6720 · FAX: (216) 791-6744
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: (216) 791-6720 | |
| Fax: (216) 791-6744 | ||
| 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.
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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.
1
Cleveland Medical Devices Inc.™
11000 CEDAR AVENUE · SUITE 439 · CLEVELAND, OHIO · PHONE: (216) 791-6720 · FAX: (216) 791-6744
- 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.