FDA product code PHW: Cold Pack And Vibrating Massager
PHW is the FDA product code for cold pack and vibrating massager. It is a Class I device, regulated under 21 CFR 890.5975 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under PHW, 1 in the last five years. The average 510(k) review took 740 days (median 740).
Definition
Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).
Classification
| Field | Value |
|---|---|
| Device name | Cold Pack And Vibrating Massager |
| Device class | Class I |
| Regulation | 21 CFR 890.5975 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PHW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 957 |
Compare with all 510(k) review times · Search every PHW clearance
Top PHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mmj Labs, LLC | 2 | 2023-05-15 |
Most recent PHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202993 | Mmj Labs, LLC | 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) | 2023-05-15 | 957 |
| K130631 | Mmj Labs, LLC | BUZZY | 2014-08-13 | 523 |
Recalls for PHW devices
openFDA lists no recalls for product code PHW.
Frequently asked questions
What is FDA product code PHW?
PHW is the FDA product code for cold pack and vibrating massager. It is a Class I device, regulated under 21 CFR 890.5975 and reviewed by the Physical Medicine panel.
What device class is PHW?
Class I, regulation 21 CFR 890.5975. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PHW?
Across 2 cleared submissions the average was 740 days from receipt to decision (median 740).
Which companies have the most PHW clearances?
Mmj Labs, LLC (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PHW
- Run a recall and safety report across every PHW manufacturer
- Watch product code PHW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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