HOMEDICS

GUDID 00031262108500

TENS & EMS pain therapy

FKA DISTRIBUTING CO., LLC

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00031262108500
• NIH Device Record Key: 8e3f08bd-75d1-472b-9907-e7ac507382dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOMEDICS
• Version Model Number: TENS-150J
• Company DUNS: 183280973
• Company Name: FKA DISTRIBUTING CO., LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00031262108500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130723

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: 2024-03-25
• Device Publish Date: 2024-03-15

On-Brand Devices [HOMEDICS]

• 00031262082268: BUBBLE BLISS ELITE
• 10031262100020: Pulse Oximeter
• 00031262099952: Pulse Oximeter
• 00031262098993: NO TOUCH Infrared Thermometer
• 10031262100204: Hot&Cold Gel Eye Mask
• 10031262099652: Percussion Massager
• 10031262098976: Double-Barrel Body Massager
• 00031262098092: Shiatsu Neck Massager
• 00031262097439: Weighted Massage Wrap
• 10031262095197: Cordless percussion body massager
• 10031262094794: CORDLESS BODY WRAP WITH VIBRATION & HEAT
• 00031262093974: Vibration Neck Massager
• 10031262093520: VIBRATION NECK MASSAGER
• 10031262093513: Shiatsu & Vibration Neck Massager
• 10031262092769: VIBRATION FOOT MASSAGER
• 10031262089196: SHIATSU+VIBRATION BODY MASSAGER WITH SOOTHING HEAT
• 10031262089172: Cordless percussion body massager
• 10031262066623: Shiatsu Neck Massager
• 00031262098986: Non-contact Infrared Body Thermometer
• 10031262101232: Non-contact Infrared Body Thermometer
• 00031262101587: Premium Wrist Blood Pressure Monitor
• 10031262101577: Automatic Arm Blood Pressure Monitor
• 10031262101560: Premium Arm Blood Pressure Monitor
• 00031262101549: WEIGHTED GEL WRAP WITH HEAT
• 00031262101532: WEIGHTED GEL HEATING PAD WITH HEAT
• 00031262101525: WEIGHTED GEL HEATING PAD - 12" X 15"
• 00031262101518: 12" X 24" HEATING PAD WITH GEL
• 00031262101501: 12" X 15" WEIGHTED HEATING PAD
• 00031262101495: 12" x 24" HEATING PAD
• 00031262101488: 12" X 24" HEATING PAD
• 00031262101471: 12" X 15" HEATING PAD
• 00031262101464: 12" X 15" HEATING PAD
• 00031262101457: 12" X 24" HEATING PAD
• 00031262101440: 12" X 15" HEATING PAD
• 00031262101433: CONTOURING BACK SUPPORT WITH HEAT
• 00031262101747: ADJUSTABLE BELT WITH INTEGRATED GEL
• 00031262101723: MULTIUSE HEATING PAD
• 00031262101716: OVERSIZED HEATING PAD
• 00031262101709: OVERSIZED HEATING PAD
• 00031262104168: LUMBAR LIFT BACK STRETCHER
• 00031262101754: WEIGHTED GEL NECK & SHOULDER WRAP
• 10031262102543: "TOTAL RECLINE MASSAGE CUSHION"
• 00031262101808: XL NECK & SHOULDER WRAP
• 00031262101792: XL NECK & SHOULDER WRAP WITH HEAT
• 00031262101785: NECK & SHOULDER WRAP WITH INSTAHEAT
• 00031262101778: NECK & SHOULDER WRAP WITH INSTAHEAT
• 00031262101761: NECK & SHOULDER WRAP WITH INSTAHEAT
• 00031262102263: WEIGHTED MASSAGING HEATING PAD
• 10031262105032: PREMIUM WRIST BLOOD PRESSURE MONITOR
• 10031262105025: PREMIUM ARM BLOOD PRESSURE MONITOR