Codes refer to specific numbers assigned to individual treatments or supplies. These include CPT codes for procedures, and HCPCS Level II codes for supplies. "Local Codes" may also be used in your area. Remember that coding is specific to the payer; therefore, it is important to know which codes are applicable. Be aware that modifiers may be required as well. The Resource-Based Relative Value System (RBRVS) may be used to determine the reimbursement rate. 890.5380 Powered
Exercise Equipment
Note: FDA has exempted almost all class I devices (with the exception of Reserved Devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment by submitting Form FDA 2891, "Initial Registration of Device Establishment," and list the generic category or classification name of the device by submitting Form FDA 2892, "Device Listing." |

