FDA Product Code PHW: Cold Pack And Vibrating Massager
Relief Of Minor Aches And Pains, Controlling The Pain Associated With Needle Sticks (injections, Iv, Venipuncture).
Leading manufacturers include Mmj Labs, LLC.
2
Total
2
Cleared
740d
Avg days
2014
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Cold Pack And Vibrating Massager Devices (Product Code PHW)
2 devices
About Product Code PHW - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code PHW since 2014, with 2 receiving FDA clearance (average review time: 740 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
PHW devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →