ANSiSTIM - PP

GUDID 08908006064267

ANSiSTIM - PP

DYANSYS INDIA PRIVATE LIMITED

Acupuncture electrical stimulation system

• Primary Device ID: 08908006064267
• NIH Device Record Key: f57e5011-6ba7-46c2-b493-e614c3f06eaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANSiSTIM - PP
• Version Model Number: ANSiSTIM - PP
• Company DUNS: 916731981
• Company Name: DYANSYS INDIA PRIVATE LIMITED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
GS1	08908006064267 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220397

FDA Product Code

• NHI: Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-24
• Device Publish Date: 2026-03-16

Devices Manufactured by DYANSYS INDIA PRIVATE LIMITED

• 08908006064083 - Drug Relief v1: 2026-03-24 Drug Relief v1
• 08908006064199 - Primary Relief: 2026-03-24 Primary Relief
• 08908006064205 - OpiEase: 2026-03-24 OpiEase
• 08908006064212 - NociRelief: 2026-03-24 NociRelief
• 08908006064229 - GiCalm: 2026-03-24 GiCalm
• 08908006064236 - NS100: 2026-03-24 NS100
• 08908006064243 - First Relief v1: 2026-03-24 First Relief v1
• 08908006064267 - ANSiSTIM - PP: 2026-03-24ANSiSTIM - PP
• 08908006064267 - ANSiSTIM - PP: 2026-03-24 ANSiSTIM - PP