FDA.report

Richmar

Primary DI
00850030915214
Brand
Richmar
Company
South Dakota Partners Inc.
Model
RM-410-010
Device description
Richmar CM2 RM-410-010
Published
2023-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications

CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850030915214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030915214008500309152148500309152140850030915214

GMDN Terms

TermDefinition
Multi-modality electrotherapy systemAn assembly of nonimplantable devices intended to apply multiple electrotherapy modalities (e.g., transcutaneous electrical nerve stimulation (TENS), galvanic stimulation, medicinal electrophoresis, interferential current) to various parts of the body for the treatment of multiple types of conditions (e.g., gynaecological, proctological, dermatological, neurological, dental and ENT). It consists of an electrically-powered control unit/generator and a handpiece with dedicated applicators/probes.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080639793
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
true
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 DIBrandModelCatalogPublished
00850030915016Dupel BLUE199332-0012023-08-02
10850030915020Mio-GuardMGF100012023-08-02
10850030915037Mio-GuardMGF100022023-08-02
00850030915054Dupel BLUE199334-0012023-08-02
00850030915085Dupel BLUE199335-0012023-08-02
00850030915115Dupel BLUE199336-0012023-08-02
10850030915150Mio-GuardMGF100032023-08-02
10850030915167Mio-GuardMGF100052023-08-02
10850030915174Mio-GuardMGF100062023-08-02
10850030915181Mio-GuardMGF100042023-08-02
00850030915191RichmarRM-A12202023-08-02
00850030915207RichmarRM-400-0462023-08-02
00850030915221RichmarRM-410-0122023-08-02
00850030915238RichmarRM-410-0142023-08-02
00850030915245RichmarRM-410-0162023-08-02
10850030915259RichmarRM-201-4552023-08-02
10850030915266RichmarRM-201-4492023-08-02
10850030915273RichmarRM-201-4532023-08-02
10850030915280RichmarRM-201-4522023-08-02
10850030915297RichmarRM-201-45522023-08-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06975869140041/Dongguan Bohuikang Technology Co., Ltd.GZJ2026-03-05
06932307410432JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.GZJ2026-03-04
06932307410425JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.GZJ2026-03-03
08032625824480GLOBUSDOMINO SRLGZJ2026-02-23
00714905117649Fab StimCOMPASS HEALTH BRANDS CORP.GZJ2026-02-06
00860163000312CMS COMPASS HEALTH BRANDS CORP.GZJ2026-02-06
00810178880799ViveVIVE HEALTH LLCGZJ2026-02-05
16971712720139KINGPAVONINIHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-01-30
06971760281357EmeTermWAT Medical Technology Inc.GZJ2026-01-23
00092237621967TwinStimCOMPASS HEALTH BRANDS CORP.GZJ2025-09-29
00860011592808Protocol SolutionsProtocol Solutions LLCGZJ2025-09-05
16971760280050EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280067EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280074EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280081EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280098EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760280104EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760281125EmeTermWAT Medical Technology Inc.GZJ2025-08-22
00092237621974TwinStimCOMPASS HEALTH BRANDS CORP.GZJ2025-08-15
06971760280251EmeTermWAT Medical Technology Inc.GZJ2025-07-31
16971760281071EmeTermWAT Medical Technology Inc.GZJ2025-07-31
00850070096003STIMPOD NMS460ALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
00850070096010STIMPOD NMS460 KitALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
00850070096027Pulsed Radio Frequency Nerve Stimulation CableALGIAMED TECHNOLOGIES USA INC.GZJ2025-05-06
30661168800010Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
30661168800027Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
10661168000164Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000174Reliefband® FlexRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
10661168000188Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
08720618311139Sonopuls 494Enraf-Nonius B.V.GZJ2025-02-11