Laser Sys*Stim 540 ME 540

GUDID 00816864020425

Therapeutic laser and light therapy

METTLER ELECTRONICS CORP.

Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 00816864020425
• NIH Device Record Key: abed5930-bc0c-4cf8-8b21-a4062fc0d0d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Sys*Stim 540
• Version Model Number: ME 540
• Catalog Number: ME 540
• Company DUNS: 008513913
• Company Name: METTLER ELECTRONICS CORP.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com
• Phone: +1(714)533-2221
• Email: service@mettlerelectronics.com

Device Dimensions

• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound
• Weight: 5.5 Pound

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *No
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816864020425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043586

FDA Product Code

• ILY: Lamp, infrared, therapeutic heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-15

Devices Manufactured by METTLER ELECTRONICS CORP.

• 10816864020064 - Sonigel Ultrasound Gel Couplants: 2021-02-19 Sonigel 1853 (4 x 5 liters)
• 10816864020323 - Sonigel Lotion with Aloe Vera: 2021-02-19 Sonigel 1864 (4 x 1 gallon)
• 00816864020111 - TENS 210: 2019-10-23 Two-channel battery-operated TENS unit
• 00816864020128 - TENS 210T: 2019-10-23 Two-channel battery-operated TENS unit with timer
• 00816864020135 - TENS 212: 2019-10-23 Two-channel digial TENS device with LCD display
• 00816864020142 - TENS*STIM 211: 2019-10-23 Stimulator, muscle, powered, for muscle conditioning
• 00816864020401 - Trio*Stim 215: 2019-10-23 Stimulator, nerve, transcutaneous, for pain relief
• 00816864020005 - Sys*Stim 206: 2019-05-23 Powered muscle stimulator, one channel neuromuscular stimulator