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510(k) K924315

Device
The Massager
Applicant
FOUR DIRECTIONS
510(k) number
K924315
Product code
LYG
Decision
Substantially Equivalent (SESE)
Decision date
1993-10-08
Date received
1992-08-26
Regulation
890.5660
Classification name
Massager, Therapeutic, Manual
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GAYLE EVERSOLE
Address
P.O. Box 55793 Seattle WA US 98155 98155

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963704MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGEShippert Medical Technologies Corp.1996-11-26
K936312MANUAL MASSAGE ROLLERMckenna & Cuneo1996-01-29
K952043BACK MASSAGEREight Corners, Inc.1995-09-01
K930613HOOKING SYSTEMAlain Machtelinckx1994-07-12
K936148STRESS HANDLERArocep Enterprises , Ltd.1994-04-21
K922366SPINE LINEDambrecine, Inc.1992-07-13
K915361THE BODY BUGGYInnova Corp.1991-12-20
K912512TAICHI STICK MASSAGERFocus International, Inc.1991-09-06
K903820THERA-CANEPro Message Co.1990-09-19
K884907BUMPY MEDICAL MASSAGE MATMedical Flotation Systems, Inc.1988-12-27
K881080DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGERFerguson Medical1988-07-21
K881081DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGERFerguson Medical1988-07-21