ohuhu

GUDID 00840001700062

It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back, joint, hip,upper extremities (arm) and lower extremities (leg) due to 6 strain from exercise or normal household work activities.

Shenzhen roundwhale technology co. LTD.

Transcutaneous electrical stimulation probe

• Primary Device ID: 00840001700062
• NIH Device Record Key: 096935b6-75f3-4567-b6f6-7b7a6859f412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ohuhu
• Version Model Number: R-C1
• 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: true
• 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	00840001700062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180956

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-11-19

Devices Manufactured by Shenzhen roundwhale technology co. LTD.

• 16971763600121 - ROOVJOY: 2024-09-02
• 16971763600084 - ROOVJOY: 2024-08-26
• 16971763600268 - ROOVJOY: 2024-08-08
• 16971763600190 - ROOVJOY: 2024-08-08
• 16971763600237 - ROOVJOY: 2024-08-08
• 06971763600919 - ROOVJOY: 2023-11-08
• 16971763600107 - ROOVJOY: 2023-10-16
• 16971763600060 - ROOVJOY: 2023-08-18