510(k) · Cleared
ClearedRehaStim 2
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 Feb 3, 2017 as substantially equivalent to K112844 (Hasomed GmbH, 2011) and 1 other predicate after a 130-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Feb 3, 2017
- Review
- 130 days
- Class
- Class II
- Product code
- GZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K841112 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK841112 Tti Rehabilatation Gym SysTherapeutic Technologies, Inc. · 1984
- 4 generations backK060032 RT300-S, Model FA100052; RT300-SP, Model FA100053Restorative Therapies, Inc. · 2006
- 3 generations backK073237 Rehastim & RehamoveHasomed GmbH · 2007
- 2 generations backK112844 Rehastim 2, Rehamove 2Hasomed GmbH · 2011
- 1 generation backK132416 Rehastim 2, Erigopro (Fes)Hasomed GmbH · 2014
- This deviceK162683 RehaStim 2Hasomed GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841112 | Tti Rehabilatation Gym Sys | Therapeutic Technologies, Inc. | 1984 | — |
| −4 | K060032 | RT300-S, Model FA100052; RT300-SP, Model FA100053 | Restorative Therapies, Inc. | 2006 | — |
| −3 | K073237 | Rehastim & Rehamove | Hasomed GmbH | 2007 | — |
| −2 | K112844 | Rehastim 2, Rehamove 2 | Hasomed GmbH | 2011 | — |
| −1 | K132416 | Rehastim 2, Erigopro (Fes) | Hasomed GmbH | 2014 | — |
| 0 (this device) | K162683 | RehaStim 2 | Hasomed GmbH | 2017 | — |
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? (2)
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 2Summary page 5…K162683 RehaMove 2 (RehaStim 2 with movement exerciser) 510(k): K112844 Device Class: class 2 device Classification: Neurology Product code: GZI Common Na… | 2011 |
| * | K132416 | Rehastim 2, Erigopro (Fes)Summary page 5…Powered Muscle Stimulator Device 2 Proprietary name: RehaStim 2; ErigoPro (FES) 510(k): K132416 Device Class: class 2 device Classification: Neurology Product code: GZI, BXB, INQ… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- 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. 2017, 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 RehaStim 2 stimulator is intended for general rehabilitation
1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Maintaining or increasing range of motion
The RehaStim 2 is an External Functional Neuromuscular Stimulator, designed for use
as stand-alone device as well as in combination with exercise equipment for walking and
cycling applications, that has been validated for compatibility by HASOMED GmbH and
should be used under the supervision of a clinician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162683: RehaStim 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162683
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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