ANKLE CALF EXERCISER PHLEBOPUMP
Device Facts
| Record ID | K952975 |
|---|---|
| Device Name | ANKLE CALF EXERCISER PHLEBOPUMP |
| Applicant | Prevent Products, Inc. |
| Product Code | BXB · Physical Medicine |
| Decision Date | Sep 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5380 |
| Device Class | Class 1 |
| 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.
Indications for Use
Indicated for bedridden and immobile patients requiring lower leg exercise to prevent venous stasis, blood pooling, and vein thrombosis, and to maintain ankle muscle tone and joint flexibility.
Regulatory Classification
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)
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