The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Foot Baths & Hand Massagers.
Device ID | K810034 |
510k Number | K810034 |
Device Name: | FOOT BATHS & HAND MASSAGERS |
Classification | Bath, Hydro-massage |
Applicant | ASSOCIATED MILLS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-06 |
Decision Date | 1981-01-15 |