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510(k) K936312

Device
MANUAL MASSAGE ROLLER
Applicant
MCKENNA & CUNEO
510(k) number
K936312
Product code
LYG  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1996-01-29
Date received
1993-11-26
Regulation
890.5660
Classification name
Massager, Therapeutic, Manual
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TRACY P BERNS
Address
1575 Eye St. NW Washington DC US 20005 20005

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
K952043BACK MASSAGEREight Corners, Inc.1995-09-01
K930613HOOKING SYSTEMAlain Machtelinckx1994-07-12
K936148STRESS HANDLERArocep Enterprises , Ltd.1994-04-21
K924315THE MASSAGERFour Directions1993-10-08
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

Legacy Summary#

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FDA Review#

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