510(k) · Cleared
ClearedFA100 SCCD (Sequential Continuous Contraction Device)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flowaid Medical Technologies, Corp · IPF Stimulator, Muscle, Powered
Cleared on Feb 14, 2017 as substantially equivalent to K050046 (Compex Technologies, Inc., 2005) after a 110-day review. Its family tree reaches back 2 generations to 1987. 5 later devices descend from it.
- Decided
- Feb 14, 2017
- Review
- 110 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K872976 (1987). 6 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK872976 Tens Pals PlusAxelgaard Mfg. Co., Ltd. · 1987
- 1 generation backK050046 Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005
- This deviceK162987 FA100 SCCD (Sequential Continuous Contraction Device)Flowaid Medical Technologies, Corp · 2017
- Descendant · cites it directly · 4 of its ownK180082 geko T-2 and geko Plus R-2Firstkind, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK193045 geko™ W-2Firstkind Limited · 2020
- Descendant · 2 generations on · 1 of its ownK181059 geko T-3 Neuromuscular StimulatorFirstkind Limited · 2018
- Descendant · 3 generations on · 0 of its ownK212762 geko W-2Firstkind Limited · 2021
- Descendant · 2 generations on · 0 of its ownK191113 geko T-2 and geko T-3 Neuromuscular StimulatorsFirstkind Limited · 2019
Most influential descendants
Showing 5 of 5 · See all- K180082geko T-2 and geko Plus R-2Firstkind, Ltd. · 2018 · cites it directly4descendants
- K193045geko™ W-2Firstkind Limited · 2020 · 2 generations on1descendant
- K181059geko T-3 Neuromuscular StimulatorFirstkind Limited · 2018 · 2 generations on1descendant
- K212762geko W-2Firstkind Limited · 2021 · 3 generations on0descendants
- K191113geko T-2 and geko T-3 Neuromuscular StimulatorsFirstkind Limited · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872976 | Tens Pals Plus | Axelgaard Mfg. Co., Ltd. | 1987 | — |
| −1 | K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S | Compex Technologies, Inc. | 2005 | — |
| 0 (this device) | K162987 | FA100 SCCD (Sequential Continuous Contraction Device) | Flowaid Medical Technologies, Corp | 2017 | — |
| +1 | K180082 | geko T-2 and geko Plus R-2 | Firstkind, Ltd. | 2018 | — |
| +2 | K193045 | geko™ W-2 | Firstkind Limited | 2020 | — |
| +2 | K181059 | geko T-3 Neuromuscular Stimulator | Firstkind Limited | 2018 | — |
| +3 | K212762 | geko W-2 | Firstkind Limited | 2021 | — |
| +2 | K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | Firstkind Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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 |
|---|---|---|---|
| * | K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SSummary page 4…or Regulatory Class: Class II Product Code: IPF Review Panel Physical Medicine D. Predicate Device: IF 3Wave - K050046 E. Device Description: The FA100 SCCD is a portable, battery powered, hand-held 4-channel electrical stimulator… | 2005 |
| † | K112348 | RS-4I Muscle Stimulator | 2012 |
| † | K031017 | Sys*Stim 208 and 208A | 2003 |
| † | K133638 | GEKO | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180082 | geko T-2 and geko Plus R-2 | 2018 | 4 |
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 17.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K180082 (Firstkind, Ltd., 2018) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K050046.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
Increasing local blood circulation
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Preventing or retarding disuse atrophy
Edema reduction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162987: FA100 SCCD (Sequential Continuous Contraction Device).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162987
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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