FDA.reportPublic FDA data

510(k) K922366

Device
SPINE LINE
Applicant
DAMBRECINE, INC.
510(k) number
K922366
Product code
LYG  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-13
Date received
1992-05-20
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
MICHAEL DAMBRO
Address
10151 University Blvd., Suite 237 Orlando FL US 32817 32817

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
K924315THE MASSAGERFour Directions1993-10-08
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases