FDA UDI
In Commercial Distribution
🇺🇸 United States
Richmar TheraTouch
DI: 00092237620397
·
Model: DQSWD2
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Richmar TheraTouch
- Primary DI
- 00092237620397
- Version / Model
- DQSWD2
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-08
- Public Version
- 3
- Public Version Date
- 2023-09-08
- Public Version Status
- Update
- Public Device Record Key
- 4c1fc207-9b88-4ebc-8872-51797218cf6d
Device Description
DX2 Shortwave Diathermy Clinical Device
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
- No
- 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 |
|---|---|---|---|---|
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11246 | Short-wave diathermy treatment system generator | A component of a short-wave therapeutic diathermy system designed to generate electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 megahertz (MHz) to 27.12 MHz applied transcutaneously to provide a deep heat within specific volumes of the body. The energy generated by this device is typically conducted using electrodes placed on the patient's skin across the area to be treated; the energy is passed between the electrode poles to treat pain, muscle spasms, and joint contractures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00092237620397 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]