IRO · Class I · 21 CFR 890.5975

FDA Product Code IRO: Vibrator, Therapeutic

Leading manufacturers include Conair Corp., Fred Sammons, Inc. and Henley Intl..

65
Total
65
Cleared
143d
Avg days
1976
Since

FDA 510(k) Cleared Vibrator, Therapeutic Devices (Product Code IRO)

65 devices
1–24 of 65
Cleared Jul 18, 1995
CONAIR FAMILY FITNESS BODY ENERGY
K950441
Conair Corp.
Physical Medicine · 172d
Cleared May 23, 1995
CONAIR BODY AND SOLE
K950410
Conair Corp.
Physical Medicine · 112d
Cleared Nov 28, 1994
SQUEEZE PLAY
K943730
Conair Corp.
Physical Medicine · 118d
Cleared Feb 02, 1994
SONASSAGE
K923238
Conair Corp.
Physical Medicine · 580d
Cleared Oct 12, 1993
HEALTLH ESSENTIALS PERSONAL MASSAGER
K924431
Conair Corp.
Physical Medicine · 406d
Cleared Oct 12, 1993
BODYTHERM
K924519
Conair Corp.
Physical Medicine · 403d
Cleared Oct 12, 1993
HEALTH ESSENTIALS MAXI MASSAGER
K924581
Conair Corp.
Physical Medicine · 397d
Cleared Oct 12, 1993
HEALTH ESSENTIALS BODY CARE MASSAGER
K924582
Conair Corp.
Physical Medicine · 397d
Cleared Oct 12, 1993
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER
K924583
Conair Corp.
Physical Medicine · 397d
Cleared Oct 12, 1993
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER
K924584
Conair Corp.
Physical Medicine · 397d
Cleared Jan 08, 1992
PAM PLUS
K913998
Kinetic Concepts, Inc.
Physical Medicine · 124d
Cleared Dec 20, 1991
TOUCH N TONE 1 MASSAGER
K915242
Conair Corp.
Physical Medicine · 37d
Cleared Oct 24, 1991
MULTI-REACH II WAND MASSAGER
K914344
Conair Corp.
Physical Medicine · 27d
Cleared May 29, 1987
VASOTRAIN 447
K871107
Henley Intl.
Physical Medicine · 71d
Cleared Jun 11, 1982
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
K821633
Fred Sammons, Inc.
Physical Medicine · 8d
Cleared Mar 04, 1981
VIBRATOR
K810446
Fred Sammons, Inc.
Physical Medicine · 13d
Cleared Jan 21, 1980
BK-5203 FACILITATION VIBRATOR ELECTRIC
K800018
Fred Sammons, Inc.
Physical Medicine · 19d
Cleared Aug 26, 1977
HEAD FACILITATION VIBRATOR BK-5210
K771279
Fred Sammons, Inc.
Physical Medicine · 74d
Cleared Dec 02, 1976
ELECTRIC VIBRATOR
K761121
Fred Sammons, Inc.
Physical Medicine · 13d

About Product Code IRO - Regulatory Context