GEM-STIM GM310PE(OTC)

GUDID 24712832961328

OTC EMS (Abdominal Training System)

GEMORE TECHNOLOGY CO., LTD.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 24712832961328
• NIH Device Record Key: a9a9f0fa-0c09-4412-ba52-1e490b4ee42e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEM-STIM
• Version Model Number: GM310PE(OTC)
• Catalog Number: GM310PE(OTC)
• Company DUNS: 658435078
• Company Name: GEMORE TECHNOLOGY CO., LTD.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712832961324 [Primary]
GS1	24712832961328 [Package]; Contains: 04712832961324; Package: Carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091833

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-12
• Device Publish Date: 2023-09-04

On-Brand Devices [GEM-STIM]

• 04712832960396: GM320PE Bottom System
• 04712832960389: GM3A10T Analog TENS
• 04712832960372: GM320T Digital TENS
• 04712832960365: GM320TE Digital Combo TENS+EMS
• 04712832960358: GM3A10T Analog TENS
• 04712832960341: OMNI GM3A50T Analog TENS with protective cover
• 04712832960334: Butterfly Electrode
• 04712832960327: Electrode Pad 40x40mm
• 04712832960303: GM3A10E Analog EMS
• 04712832960297: GM320E(C) Digital EMS
• 04712832960280: GM3A10T(0) Analog TENS
• 04712832960273: GM3A50E Analog EMS
• 04712832960266: GM3A50T Analog TENS
• 04712832960259: GM3A50T(0) Analog TENS
• 04712832960242: Analog TENS
• 04712832960235: Digital Combo TENS+EMS
• 04712832960228: Digital TENS
• 04712832960204: Digital Pre-program TENS
• 04712832960198: Digital Pre-program EMS
• 04712832960075: Electrode Pad 50x50mm
• 04712832960068: Electrode Pad 40x40mm
• 04712832960051: Lead Wire
• 04712832960044: High Voltage Pulsed Galvanic Stimulator
• 04712832960037: Digital TENS
• 04712832960020: Analog Combo (TENS+EMS)
• 04712832960013: Powered muscle stimulator, Analog EMS
• 04712832960006: Physiotherapy Stimulator Analog TENS
• 04712832960426: GM3A20T Analog TENS
• 04712832960082: Electrode Pad 45mm
• 24712832961489: OTC TENS
• 24712832961366: Digital TENS
• 24712832961144: Clinical type TENS
• 24712832960536: Clinical type EMS
• 24712832960529: Digital Combo TENS+EMS+IF
• 24712832960505: Digital Combo TENS+EMS
• 24712832960499: Digital EMS
• 24712832960482: Digital TENS
• 24712832960475: Analog Interferential
• 04712832960419: Digital EMS
• 04712832960211: GM322IF Interferential
• 24712832960512: Pre-program TENS
• 24712832961083: Interferential Stimulator
• 04712832961072: Interferential Stimulator
• 04712832961065: Interferential Stimulator
• 04712832961058: Interferential Stimulator
• 24712832961045: Interferential Stimulator
• 24712832961014: Analog Combo (TENS+EMS)
• 24712832960987: Analog EMS
• 24712832960970: Analog TENS
• 24712832960963: Analog Combo (TENS+EMS)