AccessGUDID - DEVICE: Inspirstar (B524IS02BA0)

GUDID

Device Identifier (DI) Information

Brand Name: Inspirstar
Version or Model: IS02BA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSPIRSTAR INC

Primary DI Number: B524IS02BA0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783216174 *Terms of Use

Device Description: Inspirstar IS02BA is a high-end precision medical instrument used for the relief of pain. This product can generate low intensity current pulses at microampere level (up to 400 microampere) and frequency of pulses (up to 1000Hz). This product have five therapy programs. Each program includes multiple sub-programs. There are five keys on the device for each program. No screen.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060368	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a11d6e10-c039-49bf-83db-9596500b9776
Public Version Date: June 02, 2023
Public Version Number: 8
DI Record Publish Date: March 21, 2017