COMFYTENS COMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS

GUDID 10816924020263

DIGITAL TENS WITH 5 MODES

TENSPRODUCTS, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 10816924020263
• NIH Device Record Key: c6099ba3-1bba-438b-a69a-ee277f950498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMFYTENS
• Version Model Number: COMFYTENS
• Catalog Number: COMFYTENS, COMFYTENS-JETT, COMFYTENS-TP, COMFYTENS
• Company DUNS: 121251883
• Company Name: TENSPRODUCTS, INC.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816924020266 [Primary]
GS1	00816924020396 [Package]; Contains: 00816924020266; Package: KIT-WITH 4040TC [1 Units]; In Commercial Distribution
GS1	00816924020754 [Package]; Contains: 00816924020266; Package: KIT-WITH KWTS22-TP [1 Units]; In Commercial Distribution
GS1	00816924020808 [Package]; Contains: 00816924020266; Package: KIT-WITH KWTS22-MFR [1 Units]; In Commercial Distribution
GS1	10816924020263 [Package]; Contains: 00816924020396; Package: CASE-WITH 4040TC [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071951

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2019-11-29
• Device Publish Date: 2019-11-21

Devices Manufactured by TENSPRODUCTS, INC.

• B1900540 - STIMWEAR: 2019-12-05 CONDUCTIVE PADS 2" X 3" PK/2 with 1oz CONDUCTIVE SPRAY
• B1900560 - STIMWEAR: 2019-12-05 StimWear™ CONDUCTIVE PADS 3" X 5" PK/2 with 1oz CONDUCTIVE SPRAY
• B1900570 - STIMWEAR: 2019-12-05 StimWear™ CONDUCTIVE SOCK with 1oz CONDUCTIVE SPRAY
• B1900580 - STIMWEAR: 2019-12-05 StimWear™ CONDUCTIVE ARM SLEEVE with 1oz CONDUCTIVE SPRAY
• B1900590 - STIMWEAR: 2019-12-05 StimWear™ CONDUCTIVE LEG SLEEVE with 1oz CONDUCTIVE SPRAY
• B1900600 - STIMWEAR: 2019-12-05 StimWear™ CONDUCTIVE GLOVE with 1oz CONDUCTIVE SPRAY
• B190STIMKITBACK0 - STIMWEAR: 2019-12-05 StimWear™ LUMBAR BACK CONDUCTIVE GARMENT KIT
• B190STIMKITKNEE0 - STIMWEAR: 2019-12-05 StimWear™ KNEE CONDUCTIVE KIT