Compliance Consultants has created many 510(k)
applications for Class II cardiovascular restorative
rehabilitation exercise equipment.
The CDRH classifies these as an isokinetic testing and evaluation systems for cardiovascular testing & rehabilitative exercise devices. These devices are intended for medical purposes (such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints).
Regulation Number: 21 CFR 890.1925, Product Code: Ikk
Regulation Number: 21 CFR 888.1240, Product Code: LBB
The CDRH classifies these as an isokinetic testing and evaluation systems for cardiovascular testing & rehabilitative exercise devices. These devices are intended for medical purposes (such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints).
Regulation Number: 21 CFR 890.1925, Product Code: Ikk
Regulation Number: 21 CFR 888.1240, Product Code: LBB
