(456 days)
Not Found
Not Found
No
The description focuses on a motor-driven mechanical device controlled by a simple air switch, with no mention of AI, ML, or any data processing or learning capabilities.
Yes
The device is intended to prevent vein thrombosis and maintain muscle tone and prevent stiffness in ankle joints, which are therapeutic functions.
No
The device is described as an exercise device for the lower leg to prevent vein thrombosis and maintain muscle tone and flexibility, not to diagnose any condition.
No
The device description explicitly states it is a "compact portable exercise device with motor driven foot paddles," indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ACE/PP is a physical exercise device that uses motor-driven foot paddles to move the lower leg and ankle. It does not involve the analysis of any biological samples.
- Intended Use: The intended use is to prevent vein thrombosis and maintain muscle tone and joint stiffness through physical exercise. This is a mechanical/physical intervention, not a diagnostic test.
Therefore, the ACE/PP falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACE/PP is intended to exercise the lower leg to help prevent vein thrombosis secondary to venous stasis and blood pooling in the leg. It also retains the exercise function for maintaining muscle tone and preventing stiffness in the ankle joints.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The ACE/PP is a compact portable exercise device with motor driven foot paddles. The product is controlled by the staff or the patient via an air switch. The paddles are driven in a natural and gentle dorsiflex motion.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
lower leg
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Ankle Calf Exerciser from Prevent Products, Inc., Toronto Lower Limb Model Mobilimb L2, PlexiPump from NuTech
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
§ 890.5380 Powered exercise equipment.
(a)
Identification. Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a powered treadmill, a powered bicycle, and powered parallel bars.(b)
Classification. Class I (general 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
SEP 2 5 1996
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Attachment E
510(k) Summary
1
510(k) Summary
Prevent Products Ankle Calf Exerciser & Phlebopump
General Manager
General Information
| Classification | Class II |
|---|---|
| Trade Name | ACE/PP |
| Submitter | Prevent Products, Inc |
| 1167 Ottawa Avenue | |
| St. Paul, MN 55118 | |
| (612) 457-4385 | |
| Contact | Carol Garcia |
Predicate Devices
Ankle Calf Exerciser from Prevent Products, Inc. Toronto Lower Limb Model Mobilimb L2 PlexiPump from NuTech
Device Description
The ACE/PP is a compact portable exercise device with motor driven foot paddles. The product is controlled by the staff or the patient via an air switch. The paddles are driven in a natural and gentle dorsiflex motion.
Intended Use
The ACE/PP is intended to exercise the lower leg to help prevent vein thrombosis secondary to venous stasis and blood pooling in the leg. It also retains the exercise function for maintaining muscle tone and preventing stiffness in the ankle joints.
" sting
The product meets or exceeds UL 544.
2
Summary of Substantial Equivalence
)
The ACE/PP offers the user a means to exercise the lower leg and to minimize venous stasis in bedridden and immobile patients. The ACE/PP is substantially equivalent to the predicate ACE from Prevent Products, the Toronto Lower Limb CPM and the PlexiPump. The clinical indications for use are the same as well as the basic overall design.