PHW · Cold Pack And Vibrating Massager
Physical Medicine · 21 CFR 890.5975 · Class 1
Overview
| Product Code | PHW |
|---|---|
| Device Name | Cold Pack And Vibrating Massager |
| Regulation | 21 CFR 890.5975 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202993 | Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) | Mmj Labs, LLC | May 15, 2023 | SESE |
| K130631 | BUZZY | Mmj Labs, LLC | Aug 13, 2014 | SESE |
Top Applicants
- Mmj Labs, LLC — 2 clearances
