Inspirstar, MEND, HoweRT

GUDID B524IS02LCD0

Inspirstar IS02LCD 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 multiple therapy programs. Each program includes multiple sub-programs. Screen display.

INSPIRSTAR INC

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: B524IS02LCD0
• NIH Device Record Key: a2583d82-a79e-48d5-9f77-48db1247c8cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inspirstar, MEND, HoweRT
• Version Model Number: IS02LCD
• Company DUNS: 783216174
• Company Name: INSPIRSTAR INC
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B524IS02LCD0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060368

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: 2017-03-21

Devices Manufactured by INSPIRSTAR INC

• B524IS02BAS0 - Inspirstar: 2022-07-08 Inspirstar IS02BAs is a high-end precision medical instrument used for the relief of pain. This product can generate low intensi
• B524IS02LCDS0 - Inspirstar, MEND, HoweRT, DR MITOWI: 2022-07-08 Inspirstar IS02LCDs is a high-end precision medical instrument used for the relief of pain. This product can generate low intens
• B524IS02PROS0 - Inspirstar, MEND: 2022-07-08 Inspirstar IS02PROs is a high-end precision medical instrument used for the relief of pain. This product can generate low intens
• B524IS02BA0 - Inspirstar: 2019-10-23 Inspirstar IS02BA is a high-end precision medical instrument used for the relief of pain. This product can generate low intensit
• B524IS02LCD0 - Inspirstar, MEND, HoweRT: 2019-10-23Inspirstar IS02LCD 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 multiple therapy programs. Each program includes multiple sub-programs. Screen display.
• B524IS02LCD0 - Inspirstar, MEND, HoweRT: 2019-10-23 Inspirstar IS02LCD is a high-end precision medical instrument used for the relief of pain. This product can generate low intensi
• B524IS02PRO0 - Inspirstar, MEND: 2019-10-23 Inspirstar IS02BA is a high-end precision medical instrument used for the relief of pain. This product can generate low intensit