IRO — Vibrator, Therapeutic Class I

FDA Device Classification

Classification Details

Product Code
IRO
Device Class
Class I
Regulation Number
890.5975
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K955250east health development groupQI GONG MASSAGERFebruary 8, 1996
K955160everapex design and marketingCOMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGERFebruary 8, 1996
K954203cisco salesMASSAGER THERAPUTIC, ELECTRICDecember 11, 1995
K952916kinsei shiatsuSHIATSU MASTER MASSAGER CUSHIONAugust 28, 1995
K951414champion mfgCHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIRAugust 11, 1995
K950441conairCONAIR FAMILY FITNESS BODY ENERGYJuly 18, 1995
K946382wiscco developmentSKALPI 3200May 30, 1995
K950410conairCONAIR BODY AND SOLEMay 23, 1995
K944909wahl clipperWAHL FRESH FACEMay 8, 1995
K950400ultrassageHAND MASSAGE UNITMarch 30, 1995
K945603headwatersCORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)February 9, 1995
K940582philco ushuaiaMASSAGING HELMET C.F. HANSEN DESIGNJanuary 30, 1995
K943730conairSQUEEZE PLAYNovember 28, 1994
K940837wahl clipperWAHL(R) FOOT COMFORT MASSAGERJune 9, 1994
K941412wahl clipperWAHL COMPACT COMFORT MASSAGERJune 9, 1994
K934886next waveNEXT WAVE PHYSIOACOUSTIC MATTRESSJune 9, 1994
K931638fairform mfg., coFO96 HANDY MASSAGERMarch 28, 1994
K931637fairform mfg., coA013 FEMI-FORM FACIAL MASSAGERMarch 28, 1994
K931639fairform mfg., coF183 AC-MINI MASSAGER WITH UL APROVED ADAPTORMarch 28, 1994
K931640fairform mfg., coAO11 BODY MASSAGERMarch 28, 1994