← Product Code [BXB](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/BXB) · K952975

# ANKLE CALF EXERCISER PHLEBOPUMP (K952975)

_Prevent Products, Inc. · BXB · Sep 25, 1996 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/BXB/K952975

## Device Facts

- **Applicant:** Prevent Products, Inc.
- **Product Code:** [BXB](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/BXB.md)
- **Decision Date:** Sep 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5380
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic

## 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.

## Device Story

Compact, portable, motor-driven exercise device; features foot paddles providing dorsiflexion motion. Operated by staff or patient via air switch. Used in clinical or home settings for bedridden/immobile patients. Facilitates lower leg movement to minimize venous stasis and blood pooling; maintains muscle tone; prevents ankle stiffness. Clinical benefit: prophylaxis against deep vein thrombosis.

## Clinical Evidence

No clinical data provided; bench testing only (UL 544 compliance).

## Technological Characteristics

Motor-driven foot paddles; air switch control interface; portable form factor. Meets UL 544 safety standards.

## Regulatory 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.

## Predicate Devices

- Ankle Calf Exerciser (Prevent Products, Inc.)
- Toronto Lower Limb Model Mobilimb L2
- PlexiPump (NuTech)

## Submission Summary (Full Text)

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K952975

SEP 25 1996

Attachment E

510(k) Summary

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K952975

# 510(k) Summary

## Prevent Products Ankle Calf Exerciser & Phlebopump

### 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
General Manager  |

### 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.

### Testing

The product meets or exceeds UL 544.

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# 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.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/BXB/K952975](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/BXB/K952975)

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