510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PHWClass I

Cold Pack And Vibrating Massager

21 CFR 890.5975 / Physical Medicine
FDA source (opens on fda.gov)

PHW is the FDA product code for Cold Pack And Vibrating Massager, a class I device type, regulated under 21 CFR 890.5975. FDA's definition for this code reads: "Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture)". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PHW
Device name
Cold Pack And Vibrating Massager
FDA definition
Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).
Regulation
21 CFR 890.5975
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PHW

By decision year
2 clearances under product code PHW with a decision year between 2014 and 2023, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PHW by decision year
YearClearances
20141
20231

Applicants with the most clearances

Product code PHW
Applicants holding the most 510(k) clearances under product code PHW
ApplicantClearances
Mmj Labs, LLC2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order