FDA UDI
In Commercial Distribution
🇺🇸 United States
MASTERPULS®
DI: 07630039101909
·
Model: R-SW100
·
Storz Medical AG
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MASTERPULS®
- Primary DI
- 07630039101909
- Version / Model
- R-SW100
- Catalog Number
- 43000.0002
- Company Name
- Storz Medical AG
- Labeler DUNS
- 481967776
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-01
- Public Version
- 1
- Public Version Date
- 2026-03-09
- Public Version Status
- New
- Public Device Record Key
- 1650b3c4-1e32-40aa-9421-335e2e98a918
Device Description
The MASTERPULS® R-SW100 is a ballistic pulse generator operated by compressed air.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36560 | Hand-held electric massager | An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility. | No | Active |
| 47979 | Pressure-wave skin/body contouring system | An assembly of devices using extracorporeal pulse activation technology (EPAT) and designed for acoustic wave treatment (AWT) intended primarily to reduce the appearance of cellulite through mobilization of free fatty acids and oxidative agents in tissue. It typically consists of a control unit that produces pneumatically-generated and/or electrically-generated pressure waves at selected impulse frequencies by means of one or more hand-held, skin-surface applicators. The system may also be used to treat the skin, e.g., by smoothing wrinkles, tightening muscle/connective tissue, and/or improving lymphatic drainage; it may also be used to treat minor muscle pain. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630039101909 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173692 | 000 |