Vitalcontrol 664.32

GUDID 00850003500683

SHOULDER TENS DEVICE

BEURER NORTH AMERICA, L.P.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00850003500683
• NIH Device Record Key: 1af386bb-4a05-4291-8014-355da332ef85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitalcontrol
• Version Model Number: SEM21
• Catalog Number: 664.32
• Company DUNS: 078497467
• Company Name: BEURER NORTH AMERICA, L.P.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com
• Phone: 1-800-536-0366
• Email: info@beurer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003500683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200838

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: 2021-08-09
• Device Publish Date: 2021-07-31

On-Brand Devices [Vitalcontrol]

• 10853879007970: Multifunction Thermometer
• 10853879007925: SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, por
• 20853879007496: Digital thermometer
• 10853879007468: Wrist Blood Pressure Monitor
• 10853879007451: Abdominal Toning Belt - EMS Electrical abdominal muscle stimulation
• 10853879007444: Abdominal Toning Belt
• 20853879007267: Replacement Gel Pad for use with: 1) SEM05 Vitalcontrol Mini TENS Arms & Legs Massage (Art.- No
• 20853879007168: Replacement Electrodes Set for use with SEM44 Vitalcontrol TENS / EMS device (Art.-No.: 666.64)
• 10853879007093: Tens Device Knee / Elbow 2 in 1 For the temporary relief of pain associated with sore and aching
• 10853879007048: Mini TENS Arms & Legs Massage
• 10853879007031: Mini TENS LowerBack
• 00852547004962: Upper Arm Blood Pressure Monitor
• 10852547004495: Light based, over the counter device intended for the removal of unwanted hair as well as perman
• 10850003500086: SBM67 Bluetooth® Upper Arm Blood Pressure Monitor * with standard cuff 8.7 - 14.2 in (22 - 36 c
• 10850003500055: Bluetooth® Diagnostic Scale Black (Art.- No. 747.68) Silverblue (Art.- No.747.69)
• 10850003500321: Upper Arm Blood Pressure Monitor * with cuff 8.7 - 16.5 in (22 - 42 cm)
• 10850003500482: SPEAKING BLOOD PRESSURE MONITOR - upper arm automatic-inflation electronic Sphygmomanometer, por
• 10850003500413: Three Piece EMS Pad Set Arm-Leg & Sixpack - 1 x Sixpack Pad - 2 x Arm-Leg Pads - 2 x self-adhesi
• 10850003500406: Ear thermometer
• 00850018808200: Infrared Multifunctional Thermometer
• 00850003500713: KNEE AND ELBOW TENS DEVICE
• 00850003500706: WRIST/LOWER ARM TENS DEVICE
• 00850003500690: ANKLE TENS DEVICE
• 00850003500683: SHOULDER TENS DEVICE
• 00850018808088: SPO25 Pulse Oximeter
• 10850031772073: IAN 366497_2101 Shoulder Heating Pad (Red) SHK 50 Art. No. 211.67
• 10850031772066: IAN 366497_2101 Shoulder Heating Pad (Grey) SHK 50 Art. No. 211.66
• 10850031772059: IAN 387716_2101 Abdominal and Back Heating Pad (Red) SHK 42 Art. No. 211.64
• 10850031772042: IAN 387716_2101 Abdominal and Back Heating Pad (Grey) SHK 42 Art. No. 211.63
• 10850031772035: IAN 387714_2101 Back and Neck Heating Pad (Red) SHK 34 Art. No. 211.61
• 10850031772028: IAN 387714_2101 Back and Neck Heating Pad (Grey) SHK 34 Art. No. 211.60
• 10850031772011: IAN 366501_2101 Heating Pad (Red) SHK 22 Art. No. 211.58
• 10850031772004: IAN 366501_2101 Heating Pad (Grey) SHK 22 Art. No. 211.57