FDA UDI
In Commercial Distribution
🇺🇸 United States
Vaginal Sensor Unit TTL
DI: 07540191000425
·
Model: SA6050
·
Thought Technology Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Vaginal Sensor Unit TTL
- Primary DI
- 07540191000425
- Version / Model
- SA6050
- Company Name
- Thought Technology Ltd.
- Labeler DUNS
- 209284132
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-31
- Public Version
- 6
- Public Version Date
- 2026-02-26
- Public Version Status
- Update
- Public Device Record Key
- 188487d4-6c93-41d1-b523-de2f1761b7a5
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
- 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 |
|---|---|---|---|---|
| HIR | Perineometer | Obstetrics/Gynecology | 884.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46624 | Pelvic floor muscle exerciser | A manual, non-powered device intended to be used by women to provide Kegel exercise (alternate contraction and relaxation of perineal muscles) to treat urinary stress incontinence, sexual dysfunction, or to tone the muscles of the pelvic floor. It is typically inserted into the vagina and is available in a variety of designs that commonly includes a spring-loaded, split, cantilevered cylinder that requires the voluntary contraction of the vagina to squeeze it together, or a solid metal, profiled weight that is gripped by the vaginal muscles as gravity pulls it downward. It does not include biofeedback functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540191000425 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K932149 | 000 |