PHW
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cold Pack And Vibrating Massager
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5975
- Medical specialty
- Physical Medicine
- FDA definition
- Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).
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| Record | Firm | Date | Builder |
|---|---|---|---|
| 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) (K202993) | Mmj Labs, LLC | 2023-05-15 | + Add |
| BUZZY (K130631) | Mmj Labs, LLC | 2014-08-13 | + Add |
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Every clearance here is in the API, with alerts when new ones post.