ION — Exerciser, Non-Measuring Class I

FDA Device Classification

Classification Details

Product Code
ION
Device Class
Class I
Regulation Number
890.5370
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K120783im-ableABLE-XJune 20, 2012
K885343altSTANDEXMay 1, 1989
K851065unique functional productsGRAVITY KING (DEEMED SE 87/09/18)June 13, 1985
K840551lossing orthopedicMOBILIZERMarch 23, 1984
K833870maddakKNEE WALKERNovember 29, 1983
K833249fitness equipment coFITNESSNovember 7, 1983
K832968maddakPEDAL EXERCISERSeptember 29, 1983
K831543fred sammonsADJUST. WEIGHTS-BK5171-05,10,20 BEOKJune 24, 1983
K831538fred sammonsDELUXE ADJUST-ANGLE BOARD-BK4066June 8, 1983
K831033lancer assocGIREXApril 27, 1983
K830560kaye productsEXERCISER, PASSIVE, NON MEASURINGMarch 9, 1983
K830400maddakMADDATRAINER HAND EXERCISERMarch 9, 1983
K823236lossing orthopedicBACK ON TRACK INVERSION THERAPY & EXERJanuary 21, 1983
K823623fred sammonsINFLATABLE HEAVY PLASTIC EXERCISERDecember 28, 1982
K823620fred sammonsPLASTIC ELASTOMER IN CUBE FORM EXERCISEDecember 22, 1982
K823618fred sammonsPROGRESSIVE RESISTANCE EXERCISE CUFFDecember 22, 1982
K823619fred sammonsPLASTIC ELASTOMER ENCASED IN TERRY CLOTHDecember 22, 1982
K822906i-repPHYSICAL MEDICINE & REHABILITATION EQUIPOctober 15, 1982
K821857fred sammonsBK-5305 MULTIPLE HAND GRIDJuly 2, 1982
K821855fred sammonsVISCO HANDEX-VARIOUS MODELSJuly 2, 1982