Model: TLA-20008
DI: 00851749007528
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Stimulator
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
14993963-8276-4c5d-a612-e0c394db374b
Distribution Status:
In Commercial Distribution
DUNS Number:
078877556
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00851749007528
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64948
Name: Tremor-suppression transcutaneous electrical stimulation wristband
Definition:
An electrically-powered device designed to be worn on the wrist of an adult patient with hand tremors [e.g., due to Parkinson’s disease, essential tremor (ET)] to: 1) collect motion data (e.g., tremor frequency); and 2) apply patient-specific electrical stimuli to the median and/or radial nerve(s) through the skin (transcutaneously) to help suppress or cancel the tremors. It is a wristwatch-like device that includes a motion sensor, pulse generator and electrodes; the technology may be referred to as transcutaneous afferent patterned stimulation (TAPS). This is a reusable device.
FDA Product Codes
QBC
External Upper Limb Tremor Stimulator
Premarket Submissions
Submission Number:
K253587
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling Low - @attributes - Value:
70
Item #1 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling High - @attributes - Value:
106
Item #1 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
0
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
90
Item #2 - Storage Handling Type:
Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
-20
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
45
Item #3 - Storage Handling Type:
Storage Environment Temperature