SensaTONE

GUDID 05060079210675

The SensaTONE is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

BODY CLOCK HEALTH CARE LIMITED

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 05060079210675
• NIH Device Record Key: c36ffe1f-6d3e-428f-8d4e-d9bdb4bddab9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SensaTONE
• Version Model Number: PF-SENSATONE
• Company DUNS: 504712829
• Company Name: BODY CLOCK HEALTH CARE LIMITED
• 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	05060079210675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041164

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-02-12

Devices Manufactured by BODY CLOCK HEALTH CARE LIMITED

• B364792117400 - USA 40x100 Body Clock Branded Electrodes: 2019-10-23 Indications for Use: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patie
• 05060079210101 - Profile TENS: 2019-10-23 The Profile TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment
• 05060079210217 - Flexi TENS: 2019-10-23 The Flexi TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment i
• 05060079210224 - Smart TENS: 2019-10-23 The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment i
• 05060079210262 - STIMPLUS PRO: 2019-10-23 The Body Clock Stimplus Pro is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctiv
• 05060079210675 - SensaTONE: 2019-10-23The SensaTONE is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
• 05060079210675 - SensaTONE: 2019-10-23 The SensaTONE is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in
• 05060079211283 - SensaTONE for MEN: 2019-10-23 The SensaTONE for MEN is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive trea
• 05060079211733 - Obi TENS: 2019-10-23 The Obi TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in