Reg

VacuPractor FDA Registration Information

Proprietary Name: VacuPractor
Classification Name: APPARATUS, TRACTION, NON-POWERED
Product Code: HST
Device Class: 1
Regulation Number: 888.5850
Medical Specialty: Orthopedic
Registered Establishment Name: VACUPRACTOR (TM)
Registered Establishment Number: 3008743384
Owner/Operator: VacuPractor ™
Owner/Operator Number: 10032935
Establishment Operations: Manufacturer; Specification Developer

FDA Code / Regulation: HST / 888.59 FDA Device Name: Apparatus, Traction, Non-Powered

Identification. A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.

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 888.9. 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.

VacuPractor™  is FDA Registered. We manufacture our products under the highest standards of quality control, in compliance with current Good Manufacturing Practices. The law now requires that all companies who produce medical related products must register their facility and operations with FDA.  Further, all information pertaining to a company’s address and nature of business must be current with FDA at all times.

Being FDA Registered assures our accounts, customers and the public that VacuPractor ™ is a fully disclosed company with the government. This is essential where interstate and international commerce of our products are concerned.  Issues such as public health, product safety and being in compliance with importation laws, regulations and monitoring is more effectively dealt with through the ‘FDA Registered’ policy.

Being FDA Registered does not imply that VacuPractor™ is a pharmaceutical company or that its products have been approved or certified by FDA.

Being FDA Registered means that VacuPractor™ places public safety and well-being as a top priority.

 

hello