FDA Product Code ISA: Massager, Therapeutic, Electric
Electric massagers provide accessible pain relief and muscle relaxation. FDA product code ISA covers therapeutic electric massagers cleared as medical devices.
These devices use vibration or percussive motion to stimulate soft tissue, improve circulation, and reduce muscle tension for the relief of minor muscular aches and pains. They are available in handheld and stationary configurations for self-use.
ISA devices are Class I medical devices, regulated under 21 CFR 890.5660 and reviewed by the FDA Physical Medicine panel.
Leading manufacturers include Termosalud, E.M.S Electro Medical Systems S.A and BTL Industries, Inc..
FDA 510(k) Cleared Massager, Therapeutic, Electric Devices (Product Code ISA)
About Product Code ISA - Regulatory Context
510(k) Submission Activity
100 total 510(k) submissions under product code ISA since 1977, with 100 receiving FDA clearance (average review time: 137 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under ISA have taken an average of 103 days to reach a decision - down from 138 days historically, suggesting improved FDA processing for this classification.
ISA devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →