510(k) · Cleared
ClearedRehastim 2, Erigopro (Fes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hasomed GmbH · GZI Stimulator, Neuromuscular, External Functional
Cleared on May 28, 2014 as substantially equivalent to K112844 (Hasomed GmbH, 2011) after a 299-day review. Its family tree reaches back 4 generations to 1984. 1 later device descends from it.
- Decided
- May 28, 2014
- Review
- 299 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K841112 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
- 3 generations backK060032 RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc. · 2006
- 2 generations backK073237 Rehastim & RehamoveHasomed GmbH · 2007
- 1 generation backK112844 Rehastim 2, Rehamove 2Hasomed GmbH · 2011
- This deviceK132416 Rehastim 2, Erigopro (Fes)Hasomed GmbH · 2014
- Descendant · cites it directly · 0 of its ownK162683 RehaStim 2Hasomed GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K162683RehaStim 2Hasomed GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | 1984 | — |
| −3 | K060032 | RT300-S, Model FA100052; RT300-SP, Model FA100053 | Restorative Therapies, Inc. | 2006 | — |
| −2 | K073237 | Rehastim & Rehamove | Hasomed GmbH | 2007 | — |
| −1 | K112844 | Rehastim 2, Rehamove 2 | Hasomed GmbH | 2011 | — |
| 0 (this device) | K132416 | Rehastim 2, Erigopro (Fes) | Hasomed GmbH | 2014 | — |
| +1 | K162683 | RehaStim 2 | Hasomed GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 GZI? 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 GZI device
- #1 K243828 Cionic Neural Sleeve (NS-200)score 12.9 · 13 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 |
|---|---|---|---|
| * | K112844 | Rehastim 2, Rehamove 2 Our reading of the summary gave K112344, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “RehaStim 2; RehaMove 2”. | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162683 | RehaStim 2 | 2017 | 0 |
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 30 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K162683 (Hasomed GmbH, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112844.
How does its category compare?
All GZI devicesGZI Stimulator, Neuromuscular, External Functional: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZI
110in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZI
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZI
3in 2025
MAUDE reports naming product code GZI, 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 | 4 | 81 | 0 | 1 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 6 | 139 | 0 | 3 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 299 | 0 | 2 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 6 | 168 | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 4 | 110 | 0 | 3 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ErigoPro is intended for medical purposes such as to increase tolerance to an upright or standing position in patients with circulatory, neurological, or musculoskeletal conditions.
ErigoPro is also used for:
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy / redevelop muscles
3. Increasing local blood circulation
4. Maintaining or increasing joint range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132416: Rehastim 2, Erigopro (Fes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132416
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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