Cold Pack And Vibrating Massager
The Cold Pack and Vibrating Massager is a combination physical therapy device intended to provide relief for minor aches and pains and to help control pain associated with needle sticks such as injections, IV insertions, and venipuncture procedures. It is an FDA Class 1 device regulated under 21 CFR 890.5975, subject to general controls, within the Physical Medicine (PM) medical specialty. The product code is PHW. This device is not implantable and is not life-sustaining.
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Basic Information
- Product Code
- PHW
- Device Class
- FDA class 1
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
Definition
Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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) | May 15, 2023 | Substantially Equivalent | Mmj Labs, LLC |
| K130631 | BUZZY | Aug 13, 2014 | Substantially Equivalent | Mmj Labs, LLC |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.