Rainbow

Organization name

North Coast Medical Inc.

SRN

US-MF-000009087

Manufacturer status

Active

8 warnings recorded — scroll inside the panel to see all entries.

• Consult healthcare professional before use
• Consult instructions for use
• Do not cut
• Do not use if package is damaged
• H318 – Causes serious eye damage.
• P102 – Keep out of reach of children.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• Single patient use is recommended for all NCM exercise band products. Breathe regularly and stop immediately if an exercise causes pain or discomfort. Exercise bands should be used for their intended use only. Not to be used by unsupervised children. Before each exercise session, inspect the resistance band for small nicks, tears, or punctures that may cause the band to break. If you find any flaws, discard the product and replace before performing any exercises. Do not wear jewelry that may tear or damage band. Use caution with long or sharp fingernails. Do not wrap band around uneven surfaces. Do not stretch exercise band more than two times normal length. Doing so may cause the band to snap. Snapping bands can cause serious injury, including fractures, eye, nerve and muscle damage. Wearing protective eyewear is recommended. As an added precaution, keep band and accessories away from head and face while exercising. When using with an accessory anchored to a door, make sure that the door opens away from you. Only exercise on smooth and debris free surfaces. Ensure that bands are securely fitted and/or anchored to accessories. As with any exercise program, you may experience muscle soreness over the first few days. If your pain persists, stop your exercise program and consult with health care professional. Do not exercise while experiencing pain. Store your exercise band in a protective bag or box. Do not expose bands to direct heat or sunlight. Detach band from exercise handles and accessories before storing. Not made with natural rubber latex. With heavy use, such as in a physical therapy clinic, band should be replaced every 1-2 months Do not extend farther than is comfortable.

  OTHER

Primary placement in Germany; available across 10 countries total.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.