FDA.reportPublic FDA data

Richmar

Primary DI
00850030915191
Brand
Richmar
Company
South Dakota Partners Inc.
Model
RM-A1220
Device description
Richmar Autosound RM-A1220
Published
2023-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep HeatPhysical Medicine2
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030915191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030915191008500309151918500309151910850030915191

GMDN Terms#

Term, Definition table
TermDefinition
Short-wave diathermy treatment system generatorA component of a short-wave therapeutic diathermy system designed to generate electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz applied transcutaneously to provide a deep heat within specific volumes of the body. The energy generated by this device is typically conducted using electrodes placed on the patient's skin across the area to be treated; the energy is passed between the electrode poles to treat pain, muscle spasms, and joint contractures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080639793
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030915207RichmarRM-400-0462023-08-02
00850030915641SDPSD-HP-1711-CX 2023-08-02
00850030915658SDPSD-HP-1711-LG 2023-08-02
00850030915665SDPSD-HP-1713-OS 2023-08-02
00850030915672SDPSD-HP-1905-UN 2023-08-02
00850030915689SDPSD-HP-1210-ST2023-08-02
00850030915214RichmarRM-410-0102023-08-02
00850030915221RichmarRM-410-0122023-08-02
00850030915238RichmarRM-410-0142023-08-02
00850030915245RichmarRM-410-0162023-08-02
00850030915023Mio-GuardMGF100012023-08-02
00850030915030Mio-GuardMGF100022023-08-02
00850030915153Mio-GuardMGF100032023-08-02
00850030915160Mio-GuardMGF100052023-08-02
00850030915177Mio-GuardMGF100062023-08-02
00850030915184Mio-GuardMGF100042023-08-02
00850030915252RichmarRM-201-4552023-08-02
00850030915269RichmarRM-201-4492023-08-02
00850030915276RichmarRM-201-4532023-08-02
00850030915283RichmarRM-201-4522023-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
08800016213034PLASONICHironic Co., ltd.IMI2026-03-18
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810113682778ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
00810113683379DualPulse CompactManamed, Inc.GZJ2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
00661168000037Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000044Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
08720618311139Sonopuls 494Enraf-Nonius B.V.IMG2025-02-11
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00092237624456Richmar EMG ProDrive Devilbiss HealthcareGZJ2023-08-03
00190446780601CHATTANOOGADJO, LLCGZJ2023-04-25
00190446780601CHATTANOOGADJO, LLCIMG2023-04-25
00190446780618CHATTANOOGADJO, LLCGZJ2023-04-25