Temporary Training Splint Suppliers
www.bsnmedical.com | Send Inquiry | Phone: +1-(450)-978 0738
FDA Registration: 9615780 Year Established: 2001 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Scissors, Elastic Wrap, Knee/Ankle Braces & Supports, Tape, General Medical Supplies, ...
BSN medical specializes in the areas of orthopaedics, phlebology and wound care. Cutisoft® is a range of high quality compresses, swabs and abdominal towels used for general wound care and surgery more...
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.
