FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

FOOT BATHS & HAND MASSAGERS

K Number: K810034 · Decision Jan 15, 1981
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
72
Applicant Total
14
Review Days
9

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
FOOT BATHS & HAND MASSAGERS
K Number
K810034
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5100
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Associated Mills, Inc.
Date Received
January 6, 1981
Decision Date
January 15, 1981
Product Code
ILJ
Advisory Committee
Physical Medicine
Review Advisory Committee
PM
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
ILJ Bath, Hydro-Massage

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (ILJ), ordered by most recent decision date.

View all

Other Clearances by Associated Mills, Inc.

K Number Device Name
K901459 DS60 TOOTHBRUSH SANITIZER
K872327 WHIRLPOOL AERATOR WB700, WB800, WB900, WB975
K871661 WH150 ROOM HUMIDIFIER
K862041 WM10, WM20, WM30 POWER MASSAGER
K862042 SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER
K844396 POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000
K844397 POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000
K850363 POLLENEX DIGITAL THERMOMETER T-225
K850362 POLLENEX DIGITAL THERMOMETER T-125
K841095 BP800, 850 1000
Search all 14 clearances from Associated Mills, Inc. →