FDA.reportPublic FDA data

Richmar TheraTouch

Primary DI
80092237621055
Brand
Richmar TheraTouch
Company
Compass Richmar, LLC
Model
DQLLLT
Device description
LX2 Laser Light Clinical Device with cluster applicator
Published
2019-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131259000LASER-STIMShenzhen Dongdixin Technology Co., Ltd.2013-12-27ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237621055PackageGS12In Commercial Distribution
00092237621059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223762105580092237621055
00092237621059000922376210590922376210590092237621059

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for internal (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated by a healthcare professional exclusively in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
080930531
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
80092237621475Richmar TheraTouchDQ72002019-02-08
80092237620447TensRx Body SelectDI1077-TRX2018-08-23
80092237620454TensRx Dual ComboDI3777-TRX2018-08-23
80092237900433Equipos Private Labeled SuperStim 3" Round400-888-EQUIPOS2018-09-27
80092237900884UltraStick - HJ & Associates PL203-8142019-01-18
80092237900891UltraStick - HJ & Associates PL 203-8152019-01-18
80092237900907UltraStick - HJ & Associates PL 203-8162019-01-18
30092237900919UltraStick - HJ & Asssociates PL 203-8172019-01-18
80092237900921UltraStick - HJ & Associates PL 203-8182019-01-18
80092237900938UltraStick - HJ & Associates PL 203-8192019-01-18
80092237900945UltraStick - HJ & Associates PL 203-8322019-01-18
80092237900952UltraStick - HJ & Associates PL 203-8332019-01-18
80092237902246MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
80092237900440Medical Science Private Label203-4932019-01-07
80092237900457Medidcal Science Products Private Label203-4832019-01-07
80092237900464Medical Science Products Private Label203-4822019-01-07
80092237900471Medical Science Products Private Label203-4842019-01-07
80092237901027ValueStim202-6752019-01-07
80092237901034ValueStim202-6762019-01-07
80092237900532ScripHessco 2"672 01922018-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
B5171301410Energy Flo TDP Heat LampAcu MarketILY2026-08-21
00850087184007HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688989HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00860015688996HomedicsFKA DISTRIBUTING CO., LLCILY2026-08-01
00841436126366LED Instrument CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ILY2026-07-27
00810140062833RENPHOJoicom CorporationILY2026-07-24
00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
00850087184038HomedicsFKA DISTRIBUTING CO., LLCILY2026-07-13
08800291820323HEALITE IICynosure Lutronic Technology CorporationILY2026-06-23
00860179001013FUSION PBM Plus LightDentlight Inc.ILY2026-05-27
B317KLGCHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGEHUF0GIROELTECH KLASER SRLILY2026-05-27
B317KLGUHUF0GIROELTECH KLASER SRLILY2026-05-27
G710L240Velara Lounge 24SUNSHINE USA, LLCILY2026-05-15
G710A480Velara Ascend 48SUNSHINE USA, LLCILY2026-05-11
G710E320Velara Elite 32SUNSHINE USA, LLCILY2026-05-11
00810140063014RENPHOJoicom CorporationILY2026-05-08