FDA UDI
In Commercial Distribution
🇺🇸 United States
TheraTouch SW1
DI: 00092237626887
·
Model: SW1000-HP
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- TheraTouch SW1
- Primary DI
- 00092237626887
- Version / Model
- SW1000-HP
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-04
- Public Version
- 3
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- d114e5cf-4923-4ffa-9bb0-3d8f3d5624b4
Device Description
SW1 WIRED HANDPIECE
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 47791 | Electromechanical orthopaedic extracorporeal shock wave therapy system applicator | A hand-held device designed to transfer kinetic energy to a site on the body to create mechanical shock waves, at selected amplitudes and frequencies, to treat musculoskeletal disorders. It typically includes a conduit that plugs into an electrical control unit where the energy is generated, and has a head portion that is moved over the surface of the treatment area. It is available in various sizes or has exchangeable tips to treat different musculoskeletal disorders. This is a reusable device. | No | Active |
| 67122 | Multidisciplinary extracorporeal shock wave therapy system, mobile | A mobile, electrically-powered assembly of devices designed to provide noninvasive spark-gap-generated (electrohydraulic) extracorporeal shock wave therapy [ESWT] to treat a variety of conditions (e.g., tendinopathy, plantar fasciitis, acute wounds, pelvic pain) across a range of clinical disciplines [e.g., orthopaedics, dermatology, urology]. It typically consists of a generator/control unit, a foot-switch, and a hand-held applicator designed for transcutaneous transmission of acoustic shock waves to the target area. The applied energy is intended to stimulate the body's natural healing processes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00092237626887 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]