FDA.reportPublic FDA data

Relaxis

Primary DI
00852335007076
Brand
Relaxis
Company
Relaxis
Model
09-0021-02RN
Device description
Packaged, Relaxis Battery, Medium, Rental
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVPVibratory Counter-Stimulation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVPVibratory Counter-StimulationPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN110011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN110011000SYMPHONY DEVICESensory Medical, Inc.2013-12-18OVP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852335007076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852335007076008523350070768523350070760852335007076

GMDN Terms#

Term, Definition table
TermDefinition
Restless legs syndrome vibratory counterstimulation systemA mains electricity (AC-powered) device assembly, which may include rechargeable batteries, intended to reduce the symptoms of Restless Legs Syndrome (RLS) and improve sleep through vibratory counterstimulation. It includes a controller and a vibratory pad which is placed in contact with the patient’s legs whilst in bed to reduce the sensation of restless legs. It is intended for use in the home.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(888) 475-7435xx@xx.xx

Regulatory Flags#

DUNS number
963372995
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852335007083Relaxis09-0023-012016-09-23
00852335007021Relaxis09-0020-02RF2016-09-22
00852335007038Relaxis09-0020-02RN2016-09-22
00852335007052Relaxis09-0021-022016-09-22
00852335007069Relaxis09-0021-02RF2016-09-22
00852335007090Relaxis09-0020-022016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852335007083RelaxisRelaxisOVP2016-09-23
00852335007021RelaxisRelaxisOVP2016-09-22
00852335007038RelaxisRelaxisOVP2016-09-22
00852335007052RelaxisRelaxisOVP2016-09-22
00852335007069RelaxisRelaxisOVP2016-09-22
00852335007090RelaxisRelaxisOVP2016-09-22