21 CFR 890.5660 — Massager, Therapeutic, Electric
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5660
Identification
A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.
Classification Rationale
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 § 890.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | 1 | 100 | |
| LYG | Massager, Therapeutic, Manual | 1 | 13 | |
| MWZ | Expander, Breast, External | 1 | 1 |
