FDA.report

Richmar

Primary DI
00850030915535
Brand
Richmar
Company
South Dakota Partners Inc.
Model
400-894
Device description
SuperStim 2" Foam
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
GXYElectrode, Cutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions

SubmissionSupplement
K223775000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223775000EZ-STIK ElectrodesSouth Dakota Partners2023-01-03GXY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850030915535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030915535008500309155358500309155350850030915535

GMDN Terms

TermDefinition
Transcutaneous electrical stimulation electrode, reusableAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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
00850030915214RichmarRM-410-0102023-08-02
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

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