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510(k) K120783

Device
ABLE-X
Applicant
IM-ABLE LTD
510(k) number
K120783
Product code
ION  
Decision
Substantially Equivalent (SESE)
Decision date
2012-06-20
Date received
2012-03-15
Regulation
890.5370
Classification name
Exerciser, Non-measuring
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SIGI CARON
Address
2400 Via Carillo Palos Verdes Estates CA US 90274 90274

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ION  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K885343STANDEXAlt, Inc.1989-05-01
K851065GRAVITY KING (DEEMED SE 87/09/18)Unique Functional Products1985-06-13
K840551MOBILIZERLossing Orthopedic, Inc.1984-03-23
K833870KNEE WALKERMaddak, Inc.1983-11-29
K833249FITNESSFitness Equipment Co., Inc.1983-11-07
K832968PEDAL EXERCISERMaddak, Inc.1983-09-29
K831543ADJUST. WEIGHTS-BK5171-05,10,20 BEOKFred Sammons, Inc.1983-06-24
K831538DELUXE ADJUST-ANGLE BOARD-BK4066Fred Sammons, Inc.1983-06-08
K831033GIREXLancer Assoc.1983-04-27
K830400MADDATRAINER HAND EXERCISERMaddak, Inc.1983-03-09
K830560EXERCISER, PASSIVE, NON MEASURINGKaye Products, Inc.1983-03-09
K823236BACK ON TRACK INVERSION THERAPY & EXERLossing Orthopedic, Inc.1983-01-21
K823623INFLATABLE HEAVY PLASTIC EXERCISERFred Sammons, Inc.1982-12-28
K823618PROGRESSIVE RESISTANCE EXERCISE CUFFFred Sammons, Inc.1982-12-22
K823619PLASTIC ELASTOMER ENCASED IN TERRY CLOTHFred Sammons, Inc.1982-12-22

Legacy Summary#

summary

FDA Review#

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