MWZ · Expander, Breast, External
Physical Medicine · 21 CFR 890.5660 · Class 1
Overview
| Product Code | MWZ |
|---|---|
| Device Name | Expander, Breast, External |
| Regulation | 21 CFR 890.5660 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770082 | SALONMAY BUSTLINE INCREASER | Gamma Enterprises, Inc. | Mar 16, 1977 | SESE |
Top Applicants
- Gamma Enterprises, Inc. — 1 clearance
