The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Wm10, Wm20, Wm30 Power Massager.
Device ID | K862041 |
510k Number | K862041 |
Device Name: | WM10, WM20, WM30 POWER MASSAGER |
Classification | Massager, Therapeutic, Electric |
Applicant | ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago, IL 60606 |
Contact | John Jiambalvo |
Correspondent | John Jiambalvo ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago, IL 60606 |
Product Code | ISA |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-28 |
Decision Date | 1986-06-17 |