MASTERPULS® 43000.0002

GUDID 07630039101909

The MASTERPULS® R-SW100 is a ballistic pulse generator operated by compressed air.

Storz Medical AG

Hand-held electric massager

• Primary Device ID: 07630039101909
• NIH Device Record Key: 1650b3c4-1e32-40aa-9421-335e2e98a918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTERPULS®
• Version Model Number: R-SW100
• Catalog Number: 43000.0002
• Company DUNS: 481967776
• Company Name: Storz Medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630039101909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173692

FDA Product Code

• ISA: Massager, Therapeutic, Electric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-09
• Device Publish Date: 2026-03-01

On-Brand Devices [MASTERPULS®]

• 07630039101169: The MASTERPULS® ONE is a compressed air-operated ballistic pressure wave generator.
• 07630039101817: Pulse Activation Therapy System
• 07630039101909: The MASTERPULS® R-SW100 is a ballistic pulse generator operated by compressed air.