Equate

GUDID 06970742221428

Equate Pain Therapy This is intended for the relief of pain associated with sore or aching muscles in the following anatomical locations: the lower back, shoulders, arms and legs due to strain from exercise or ADL’s (activities of daily living) principally regular household and work activities.

Guangzhou Xinbo Electronic Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970742221428
• NIH Device Record Key: 9dff2326-91bd-4896-8cee-67fb16b74cd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equate
• Version Model Number: P.T.S-II
• Company DUNS: 530683813
• Company Name: Guangzhou Xinbo Electronic 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970742221428 [Primary]

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2020-03-09
• Device Publish Date: 2020-03-01

Devices Manufactured by Guangzhou Xinbo Electronic Co., Ltd.

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• 06970742220292 - DR-HOS: 2023-11-20 Adjustable Pillow – Children size
• 06970742220308 - DR-HOS: 2023-11-20 Adjustable Pillow – Travel size
• 06970742220315 - DR-HOS: 2023-11-20 Adjustable Pillow – Leg
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• 06970742220162 - DR -HOS: 2022-03-09 Back Belt with Electrodes (sticky gel type)
• 06970742220179 - DR -HOS: 2022-03-09 Knee and Lower Leg Band with Electrodes (Fabric type)