MEDICAL DEVICE - REQUIRES PROFESSIONAL CONSULTATION
This Digital Knee CPM (Continuous Passive Motion) Device is a registered medical device designed for post-operative knee rehabilitation and recovery under healthcare professional guidance.
Important: This device should only be used as directed by a qualified healthcare professional (orthopedic surgeon, physical therapist, or physician). Not for unsupervised use.
FDA Disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Clinical Indications
Intended Use (Per FDA/CE Registration):
- Post-operative knee surgery rehabilitation
- Range of motion restoration after surgery
- Prevention of joint stiffness post-surgery
- Circulation improvement during recovery
- Under medical supervision only
Key Features
- Medical-grade CPM device for knee rehabilitation
- Adjustable speed and range of motion settings
- Digital control panel for precise adjustments
- Suitable for home use with professional guidance
- Dual voltage (110V/220V) for international use
- Quiet motor operation
- Comfortable padding and support
Contraindications
DO NOT USE if you have:
- Unstable fractures
- Active infections
- Deep vein thrombosis (DVT)
- Severe osteoporosis
- Any condition not approved by your surgeon
Consult your healthcare provider before use.
Directions for Use
IMPORTANT: Follow your healthcare professional's specific instructions.
- Review all instructions with your healthcare provider
- Ensure device is on stable, flat surface
- Position leg as instructed by medical professional
- Set range of motion as prescribed
- Set speed as prescribed
- Use for duration recommended by healthcare provider
- Monitor for discomfort or complications
- Stop immediately if pain occurs
- Report any issues to healthcare provider
- Do not adjust settings without medical authorization
Safety Information
MEDICAL DEVICE - USE ONLY AS DIRECTED
- Requires prescription or medical recommendation
- Use only under healthcare professional guidance
- Not for unsupervised use
- Follow all medical instructions precisely
- Report adverse events to healthcare provider immediately
- Keep out of reach of children
- Do not modify device settings without authorization
Disclaimer
This is a registered medical device. Use only as directed by a qualified healthcare professional.
This device is intended for post-operative rehabilitation under medical supervision. It is not intended for general wellness or unsupervised use. Individual results vary. Consult your healthcare provider for proper use and monitoring.
FAQs
1. Is this a medical device?
Answer: Yes. This is a Class II medical device registered with [FDA/CE] for post-operative knee rehabilitation.
2. Do I need a prescription?
Answer: You should consult with your healthcare provider (surgeon, physician, physical therapist) before using this device.
3. Can anyone use this?
Answer: No. This device is for post-operative rehabilitation and should only be used under medical guidance.
4. What is this device used for?
Answer: Post-surgical knee rehabilitation to restore range of motion and prevent stiffness after orthopedic surgery.
5.Do I need a prescription or doctor's recommendation to use this CPM device?
Answer: Yes, you should consult with a qualified healthcare professional before using this device. CPM devices are typically prescribed or recommended by orthopedic surgeons, physicians, or physical therapists as part of a post-surgical rehabilitation program.
6. Is training required?
Answer: Yes. Your healthcare provider will instruct you on proper use, settings, and duration.
7. What if I experience pain?
Answer: Stop using immediately and contact your healthcare provider.
8. Can I adjust the settings myself?
Answer: Only adjust settings as authorized by your healthcare professional.
9. How long should I use this?
Answer: Follow your healthcare provider's specific recommendations for duration and frequency.
10. Is this covered by insurance?
Answer: Contact your insurance provider. Many policies cover CPM devices when prescribed post-surgery.