ePower® T2 DIGITAL TENS T2 DIGITAL TENS

GUDID 10815290019413

ePower® T2 DIGITAL TENS

CLINICAL HEALTH SERVICES, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 10815290019413
• NIH Device Record Key: d0aebeb4-13d1-4b59-a0e3-abc787deceb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ePower® T2 DIGITAL TENS
• Version Model Number: T2 DIGITAL TENS
• Catalog Number: T2 DIGITAL TENS
• Company DUNS: 004416769
• Company Name: CLINICAL HEALTH SERVICES, 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815290019416 [Primary]
GS1	10815290019413 [Package]; Contains: 00815290019416; Package: Master Case [32 Units]; In Commercial Distribution

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: 2023-09-25
• Device Publish Date: 2023-09-17

Devices Manufactured by CLINICAL HEALTH SERVICES, INC.

• 10815290019406 - ePower® T1 TENS UNIT: 2023-09-25 ePower® T1 TENS UNIT
• 10815290019413 - ePower® T2 DIGITAL TENS: 2023-09-25ePower® T2 DIGITAL TENS
• 10815290019413 - ePower® T2 DIGITAL TENS: 2023-09-25 ePower® T2 DIGITAL TENS
• 10815290019420 - ePower® TE2 COMBO TENS & EMS: 2023-09-25 ePower® TE2 COMBO TENS & EMS
• 10815290019239 - ePower®: 2023-07-24 ePower® E1 EMS UNIT: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back
• 10815290019246 - ePower®: 2023-07-24 ePower® E2 DIGITAL EMS: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low b
• 10815290019161 - Clinical Health Services, Inc.: 2023-06-01 R95D 3.75" Round, 3.75 Round Electrode, Standard Pin
• 10815290018881 - Clinical Health Services, Inc.: 2022-11-01 TC120R-WC, 2" Round electrodes, white cloth, carbon, plastic zip lock
• 10815290018720 - Therapist’s Choice® TENS 3MT: 2022-06-10 Therapist’s Choice® TENS 3MT: It is used for temporary relief of pain associated with sore and aching muscles in the shoulde