FDA UDI
In Commercial Distribution
🇺🇸 United States
TrueStim
DI: 00851640007900
·
Model: HD-08A(TSG-A1)
·
Hi-Dow International Incorporated
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TrueStim
- Primary DI
- 00851640007900
- Version / Model
- HD-08A(TSG-A1)
- Company Name
- Hi-Dow International Incorporated
- Labeler DUNS
- 124034476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-30
- Public Version
- 2
- Public Version Date
- 2021-11-03
- Public Version Status
- Update
- Public Device Record Key
- b91282c6-b01a-4c8c-b34e-47d07cc803b8
Device Description
Pulsed Electromagnetic Field Wrap,,LUMBAR WRAP Black
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | Physical Medicine | 890.5290 | 2 |
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34668 | Short-wave diathermy treatment system, home-use | An assembly of devices designed to be operated by a patient in the home to provide therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency bands of 13 megahertz (MHz) to 27.12 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. This system is typically used to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851640007900 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202337 | 000 |