FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTACISER PERINEAL MUSCLE EXERCISER
K Number: K892888
·
Decision Oct 5, 1989
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
50
Review Days
168
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EXTACISER PERINEAL MUSCLE EXERCISER
- K Number
- K892888
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Bivona Medical Technologies
- Date Received
- April 20, 1989
- Decision Date
- October 5, 1989
- Product Code
- HIR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIR | Perineometer | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIR), ordered by most recent decision date.
Pelvic Floor Exerciser (PF01)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Vaginal Tactile Ultrasound Imager
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Perifit Care+
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Perifit
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Bivona Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K952700 | SUPERSLICK | Oct 31, 1995 | Substantially Equivalent |
| K942025 | BURGET NASAL STENT | Oct 27, 1995 | Substantially Equivalent |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | Oct 27, 1994 | Substantially Equivalent |
| K935053 | BIVONA NASAL TURBINATE STENT | Jul 1, 1994 | Substantially Equivalent |
| K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE | Oct 6, 1993 | Substantially Equivalent |
| K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE | Aug 10, 1993 | Substantially Equivalent |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | Jan 7, 1993 | Substantially Equivalent |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | Dec 29, 1992 | Substantially Equivalent |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | Jul 27, 1992 | Substantially Equivalent |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | Jun 29, 1992 | Substantially Equivalent |