510(k) · Cleared
ClearedIeva Rehabilitative Positional Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remendium Labs, LLC · HIR Perineometer
Cleared on Oct 9, 2014 as substantially equivalent to K013653 (Hollister, Inc., 2002) after a 286-day review. Its family tree reaches back 2 generations to 1989. 4 later devices descend from it.
- Decided
- Oct 9, 2014
- Review
- 286 days
- Class
- Class II
- Product code
- HIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891774 (1989). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK891774 Contimed II Biofeedback Dev Treat of Urin IncontiHollister, Inc. · 1989
- 1 generation backK013653 Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure…Hollister, Inc. · 2002
- This deviceK133990 Ieva Rehabilitative Positional DeviceRemendium Labs, LLC · 2014
- Descendant · cites it directly · 3 of its ownK180637 leva Pelvic Floor TrainerRenovia, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK192270 LEva Pelvic Digital Health SystemRenovia, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK212495 Leva Pelvic Health SystemRenovia, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK213913 leva Pelvic Health SystemRenovia, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K180637leva Pelvic Floor TrainerRenovia, Inc. · 2018 · cites it directly3descendants
- K192270LEva Pelvic Digital Health SystemRenovia, Inc. · 2019 · 2 generations on2descendants
- K212495Leva Pelvic Health SystemRenovia, Inc. · 2021 · 3 generations on1descendant
- K213913leva Pelvic Health SystemRenovia, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891774 | Contimed II Biofeedback Dev Treat of Urin Inconti | Hollister, Inc. | 1989 | — |
| −1 | K013653 | Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe | Hollister, Inc. | 2002 | — |
| 0 (this device) | K133990 | Ieva Rehabilitative Positional Device | Remendium Labs, LLC | 2014 | — |
| +1 | K180637 | leva Pelvic Floor Trainer | Renovia, Inc. | 2018 | — |
| +2 | K192270 | LEva Pelvic Digital Health System | Renovia, Inc. | 2019 | — |
| +3 | K212495 | Leva Pelvic Health System | Renovia, Inc. | 2021 | — |
| +4 | K213913 | leva Pelvic Health System | Renovia, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HIR device
- #1 K252748 Pelvic Floor Exerciser (PF01)score 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013653 | Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure ProbeSummary page 4…InCare Pressure Biofeedback Vaginal Probe (K013653) 1.1 Device Description The leva Rehabilitative Positional Device is a device specifically designed to facilit… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180637 | leva Pelvic Floor Trainer | 2018 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180637 (Renovia, Inc., 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HIR devicesHIR Perineometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HIR
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIR
187in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIR
No recall names HIR since 2007.
Adverse event reports per year · HIR
1in 2024
MAUDE reports naming product code HIR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 166 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 3 | 29 | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 3 | 187 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ieva Pelvic Floor Trainer is intended for the purpose of rehabilitation and
training of weak pelvic floor muscles for the treatment of stress, mixed and mild-
moderate urge incontinence in women. This device interacts with the user via
smart phone technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133990: Ieva Rehabilitative Positional Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133990
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026