Cntrl+ Bladder Support Pessary
The Cntrl+ Bladder Support Pessary is inserted into the vagina to support the urethra and reduce urine leakage with physical activity. It is intended for women over 18 who experience stress…
The Cntrl+ Bladder Support Pessary is inserted into the vagina to support the urethra and reduce urine leakage with physical activity. It is intended for women over 18 who experience stress urinary incontinence, including leakage during coughing, sneezing or exercise.
The cone-shaped pessary is made from medical-grade Santoprene. Small, Medium and Large options are available, with the appropriate size determined and prescribed by a physician.
Listed Item
The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence). Starter Kit containing 3 devices: Small (GS1 #09903124199456), Medium (GS1 #09903124199692), Large (GS1 #09903124199906). Each device is sold individually as well.
Daily Use
The device is reusable by a single patient after cleaning. It may be worn for up to 12 hours in a 24-hour period, allowing it to provide support during the selected part of the day.
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| B&A Precision Silicone Rubber (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Guangzhou Fame Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Cntrl+ Inc., Canada |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Manufacturer |
| 510(k) | K240798 |
| Record published | 2025-08-22 |
| Record revised | 2026-05-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 37.7 to 45.2 mm; height 54.74 to 60.54 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Large | Outer Diameter 45.2 mm | In distribution | |
| Small | Outer Diameter 37.7 mm | In distribution | |
| Medium | Outer Diameter 40.6 mm | In distribution | |
| Starter Kit (S, M, L) | Outer Diameter 37.7 mm | 3 | In distribution |
| Starter Kit (S, M, L) | Outer Diameter 37.7 mm | 3 | In distribution |
| Large | Outer Diameter 45.2 mm | In distribution | |
| Small | Outer Diameter 37.7 mm | In distribution | |
| Medium | Outer Diameter 40.6 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pessary, Vaginal | Panpac Medical Corporation | 628 |
| Milex | Coopersurgical, Inc. | 592 |
| Bioteque America, Inc. | Bioteque America, Inc. | 221 |
| Bioteque | Bioteque Taiwan Ltd. | 209 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 189 |
| HNM Women Care | HNM Stainless, LLC. | 187 |
| Medline | Medline Industries, Inc. | 162 |
| Marina Medical | Marina Medical Instruments, Inc. | 144 |
| EvaCare | Personal Medical Corp. | 128 |
| Hayden Medical | Hayden Medical Inc | 81 |
| Premier | Premier Dental Products Co. | 58 |
| LTL Medical | Bioteque Taiwan Ltd. | 56 |
Showing 12 of 180. All products under Pessary, Vaginal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240798 | 2024-12-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.