510(k) · Cleared
ClearedAir-Flex with Auto-Distraction
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill Laboratories Co. · JFB Table, Physical Therapy, Multi Function
Cleared on Dec 14, 2006 as substantially equivalent to K932810 (Hill Laboratories Co., 1995) after a 72-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Dec 14, 2006
- Review
- 72 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932810 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK932810 The Hill Adjustable Air-Flex ModelHill Laboratories Co. · 1995
- This deviceK063034 Air-Flex with Auto-DistractionHill Laboratories Co. · 2006
- Descendant · cites it directly · 0 of its ownK241193 AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and…Marzzan Lucas Jorge · 2025
- Descendant · cites it directly · 0 of its ownK092731 Vibro-TracPneumex, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932810 | The Hill Adjustable Air-Flex Model | Hill Laboratories Co. | 1995 | — |
| 0 (this device) | K063034 | Air-Flex with Auto-Distraction | Hill Laboratories Co. | 2006 | — |
| +1 | K241193 | AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) | Marzzan Lucas Jorge | 2025 | — |
| +1 | K092731 | Vibro-Trac | Pneumex, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2025 | 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 JFB? 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 JFB device
- #1 K240168 N7-Sscore 9.8 · 7 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 |
|---|---|---|---|
| * | K932810 | The Hill Adjustable Air-Flex ModelSummary page 2…2006 9. Device Description The AIR-FLEX with AUTO-DISTRACTION is a modification of the AIR-FLEX table originally cleared under K932810 on 02/17/1995. This new platform will replace the model originally cleared under K932810. The device is a Hi-… | 1995 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K241193 (Marzzan Lucas Jorge, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JFB devicesJFB Table, Physical Therapy, Multi Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JFB
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFB
No recall names JFB since 2007.
Adverse event reports per year · JFB
1in 2024
MAUDE reports naming product code JFB, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 3 | 162 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Air-Flex is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion and muscle relaxation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063034: Air-Flex with Auto-Distraction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063034
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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