Trio*Stim 215 ME 215

GUDID 00816864020401

Stimulator, nerve, transcutaneous, for pain relief

METTLER ELECTRONICS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system

Primary Device ID	00816864020401
NIH Device Record Key	1161f60a-156b-4768-a941-17dc94830b4e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Trio*Stim 215
Version Model Number	ME 215
Catalog Number	ME 215
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
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
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	168 Gram
Weight	168 Gram
Weight	168 Gram
Weight	168 Gram
Weight	168 Gram
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram
Device Size Text, specify	0
Weight	168 Gram

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *No
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816864020401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K990787

FDA Product Code

GZJ	STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

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	2019-10-23
Device Publish Date	2016-09-15

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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	2019-10-23Stimulator, nerve, transcutaneous, for pain relief
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