Insurance Coding
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
97110 Therapeutic procedure, one or more areas, each 15 min.Therapeutic exercises to develop strength and endurance, range of motion and flexibility.
97112 Therapeutic procedure, one or more areas, each 15 min.Neuromuscular re-education of movement, balance, coordination, kinesthetic sense, posture, and proprioception.
97530 Therapeutic activities, direct hands-on, each 15 minutes. Use of dynamic activities to improve functional performance with direct contact by the provider.
Product Classification Database
Device bars parallel, powered
Regulation Description Powered exercise equipment.
Regulation Medical Specialty physical medicine
Review Panel physical medicine
Product Code IRR
Submission Type 510(k) exempt
Regulation Number 890.5380
Device Class 1
GMP Exempt? No
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."
Request for Evaluation and Consignment
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