Counter

GUDID 06970368250017

Pain Therapy Device is a new generation of effective health-care device developed based on physics, bionics, electrobiology and modern microelectronics as well as a lot of clinical practice. The device is used for temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, neck, upper extremities(arm), and lower extremities(leg) due to strain from exercise or normal household work activities.

Counter Scientific Development (GZ) Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970368250017
• NIH Device Record Key: 9ec935fb-7dd5-4a12-a428-32149d5ea31e
• Commercial Distribution Discontinuation: 2021-03-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Counter
• Version Model Number: PTS-IV
• Company DUNS: 529449417
• Company Name: Counter Scientific Development (GZ) 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970368250017 [Primary]
GS1	26970368250011 [Package]; Package: [12 Units]; In Commercial Distribution
GS1	36970368250018 [Package]; Package: [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161537

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: 2021-03-16
• Device Publish Date: 2021-03-08