SuperStim Electrodes

GUDID 00853904006889

SuperStim 7.6cm (3") Round (Foam), Case of 10

Compass Richmar, LLC

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00853904006889
• NIH Device Record Key: 40b61d36-05ec-425d-b0b2-fce877e56eee
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SuperStim Electrodes
• Version Model Number: 400-892
• Company DUNS: 080930531
• Company Name: Compass Richmar, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 1-888-549-5005
• Email: customerservice@richmarweb.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853904006889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050469

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-31
• Device Publish Date: 2016-09-01

On-Brand Devices [SuperStim Electrodes]

• 80092237900334: SuperStim 7.6cm x 13cm (3" x 5") Rectangle (Cloth)
• 30092237900322: SuperStim 7.6cm x 13cm (3" x 5") Rectangle (Foam)
• 80092237900310: SuperStim 3cm (1.25") Round (Foam)
• 80092237900303: SuperStim 3cm (1.25") Round (Cloth)
• 80092237900297: SuperStim 7.6cm (3") Round (Foam)
• 80092237900280: SuperStim 7.6cm (3") Round (Cloth)
• 80092237900273: SuperStim 5cm x 9cm (2" x 3.5") Rectangle (Foam)
• 80092237900266: SuperStim 5cm x 9cm (2" x 3.5") Rectangle ( Cloth)
• 80092237900259: SuperStim 5cmx5cm(2"x2") Square (Foam)
• 80092237900242: SuperStim 5cmx5cm(2"x2") Square (Cloth)
• 80092237900235: SuperStim 5cm (2") Round (Foam)
• 80092237900228: SuperStim 5cm (2")Round (Cloth)
• 80092237900211: SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle ( Foam)
• 30092237900209: SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle (Cloth)
• 80092237900198: SuperStim 4 x 6cm (1.5" x 2.5") Oval (Foam)
• 80092237900181: SuperStim 4 x 6cm (1.5" x 2.5") Oval (Cloth)
• 00853904006988: SuperStim 4 x 6cm (1.5" x 2.5") Oval (Foam), Case of 10
• 00853904006971: SuperStim 4 x 6cm (1.5" x 2.5") Oval (Cloth), Case of 10
• 00853904006964: SuperStim 7.6cm x 13cm (3" x 5") Rectangle (Foam), Case of 10
• 00853904006957: SuperStim 7.6cm x 13cm (2" x 3.5") Rectangle (Cloth)*, Case of 10
• 00853904006940: SuperStim 5cm x 9cm (2" x 3.5") Rectangle (Foam), Case of 10
• 00853904006933: SuperStim 5cm x 9cm (2" x 3.5") Rectangle ( Cloth), Case of 10
• 00853904006926: SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle ( Foam), Case of 10
• 00853904006919: SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle (Cloth), Case of 10
• 00853904006902: SuperStim 3cm (1.25") Round (Foam), Case of 10
• 00853904006896: SuperStim 3cm (1.25") Round (Cloth), Case of 10
• 00853904006889: SuperStim 7.6cm (3") Round (Foam), Case of 10
• 00853904006858: SuperStim 7.6cm (3") Round (Cloth), Case of 10
• 00853904006735: SuperStim 5cmx5cm(2"x2") Square (Foam), Case of 10
• 00853904006728: SuperStim 5cmx5cm(2"x2") Square (Cloth), Case of 10
• 00853904006711: SuperStim 5cm (2") Round (Foam), Case of 10
• 00853904006704: SuperStim 5cm (2")Round (Cloth), Case of 10
• 00853904006568: SuperStim 4 x 6cm (1.5" x 2.5") Oval (Foam)
• 00853904006551: SuperStim 4 x 6cm (1.5" x 2.5") Oval (Cloth)
• 00853904006544: SuperStim 7.6cm x 13cm (3" x 5") Rectangle (Foam)
• 00853904006537: SuperStim 7.6cm x 13cm (2" x 3.5") Rectangle (Cloth)
• 00853904006520: SuperStim 5cm x 9cm (2" x 3.5") Rectangle (Foam)
• 00853904006513: SuperStim 5cm x 9cm (2" x 3.5") Rectangle ( Cloth)
• 00853904006506: SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle ( Foam)
• 00853904006490: SuperStim 4cm x 9cm (1.5 x 3.5") Rectangle (Cloth)
• 00853904006483: SuperStim 3cm (1.25") Round (Foam)
• 00853904006476: SuperStim 3cm (1.25") Round (Cloth)
• 00853904006469: SuperStim 7.6cm (3") Round (Foam)
• 00853904006452: SuperStim 7.6cm (3") Round (Cloth)
• 00853904006445: SuperStim 5cmx5cm(2"x2") Square (Foam)
• 00853904006438: SuperStim 5cmx5cm(2"x2") Square (Cloth)
• 00853904006421: SuperStim 5cm (2") Round (Foam)
• 00853904006414: SuperStim 5cm (2")Round (Cloth)
• 00853279007047: 3" x 5" Rectagulo (Hule)
• 00850958007510: SuperStim 7.6cm x 13cm (3"x5") Rectangle (Cloth)