TENS*STIM 211 ME 211

GUDID 00816864020142

Stimulator, muscle, powered, for muscle conditioning

METTLER ELECTRONICS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

Primary Device ID	00816864020142
NIH Device Record Key	2628461d-e970-4510-9472-d6331be5044a
Commercial Distribution Status	In Commercial Distribution
Brand Name	TENS*STIM 211
Version Model Number	ME 211
Catalog Number	ME 211
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	false
OTC Over-The-Counter	true

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

Device Size Text, specify	0
Device Size Text, specify	0
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Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0
Weight	74 Gram
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
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
Storage Environment Temperature	Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816864020142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141299

FDA Product Code

NGX	STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

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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