ROOVJOY

GUDID 16971763600237

Shenzhen roundwhale technology co. LTD.

Transcutaneous electrical stimulation probe

• Primary Device ID: 16971763600237
• NIH Device Record Key: 3491dbb3-998f-4fbf-b1cc-330a4fc906af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROOVJOY
• Version Model Number: MINI TENS COMBO
• Company DUNS: 544587118
• Company Name: Shenzhen roundwhale technology 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971763600681 [Primary]
GS1	16971763600237 [Package]; Contains: 06971763600681; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231423

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: 2024-08-08
• Device Publish Date: 2024-07-31

On-Brand Devices [ROOVJOY]

• 00840001700116: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 00840001700093: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 00840001700086: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 18400017010020: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 18400017010013: TENS mode It is used for temporary relief of pain associated with sore and aching muscles in the
• 00840001700079: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700038: The EMS stimulation program stimulates healthy muscles in order to improve and facilitate muscle
• 10840001700021: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700014: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 00840001700147: Lead Wire
• 10840001700090: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700083: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700076: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700069: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700007: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700120: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700113: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700106: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700144: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700151: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700182: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 00840001700239: It is used for temporary relief of pain associated with sore and aching muscles in the shoulder,
• 10840001700199: It is used for temporary relief of pain associated with sore and aching muscles in the neck, sho
• 16971763600060: M101A
• 16971763600107: R-C101D
• 06971763600919: R-C101N
• 16971763600237: MINI TENS COMBO
• 16971763600190: R-C101W
• 16971763600268: R-C101B
• 16971763600084: self-adhesive electrode
• 16971763600121: R-C101K