510(k) · Cleared
ClearedHang Ups Power II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stl Intl., Inc. · ITH Equipment, Traction, Powered
Cleared on Dec 20, 1999 as substantially equivalent to K821002 (Inverchair Marketing, Inc., 1982) and 2 other predicates after a 206-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Dec 20, 1999
- Review
- 206 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K894435 (1989). 4 ancestors in all, the oldest K821002 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 1 generation backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- This deviceK991835 Hang Ups Power IIStl Intl., Inc. · 1999
- Descendant · cites it directly · 0 of its ownK072064 Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072064Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −1 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| 0 (this device) | K991835 | Hang Ups Power II | Stl Intl., Inc. | 1999 | — |
| +1 | K072064 | Gravilax Traction System | Therapeutic Clinical Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 ITH? 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 ITH device
- #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K821002 | InverchairSummary page 1…Powered Gravity-Assisted Traction Table, Inversion Table Classification Name: Equipment, Traction, Powered Predicate Devices: F5000-Series 510(k) Exempt HST InverChair K821002 ITH Vax-D K951622 ITH ATT-300 K944699 ITH Midland Vari-rac I K862746 ITH Device Description: : The InvertAlign is a non-invasive… | 1982 |
| * | K951622 | Vax-D Therapeutic TableSummary page 1…sisted Traction Table, Inversion Table Classification Name: Equipment, Traction, Powered Predicate Devices: F5000-Series 510(k) Exempt HST InverChair K821002 ITH Vax-D K951622 ITH ATT-300 K944699 ITH Midland Vari-rac I K862746 ITH Device Description: : The InvertAlign is a non-invasive traction device th… | 1996 |
| * | K944699 | ATT-300Summary page 1…e, Inversion Table Classification Name: Equipment, Traction, Powered Predicate Devices: F5000-Series 510(k) Exempt HST InverChair K821002 ITH Vax-D K951622 ITH ATT-300 K944699 ITH Midland Vari-rac I K862746 ITH Device Description: : The InvertAlign is a non-invasive traction device that utilizes gravity… | 1995 |
| Kept off the family tree | K862746 | FDA’s K862746 is EM Diagnostic Ecg Electrode Our OCR of the scanned summary read K862746, FDA’s number for EM Diagnostic Ecg Electrode (Electromed Intl., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Midland Vari-rac I”. Kept off the family tree. Summary page 1…ion Name: Equipment, Traction, Powered Predicate Devices: F5000-Series 510(k) Exempt HST InverChair K821002 ITH Vax-D K951622 ITH ATT-300 K944699 ITH Midland Vari-rac I K862746 ITH Device Description: : The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The user str… | 1986 |
| * | — | F5000-Series Named without a submission number |
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 |
|---|---|---|---|
| K072064 | Gravilax Traction System | 2008 | 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 10 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072064 (Therapeutic Clinical Technologies, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITH
132in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITH
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ITH
3in 2025
MAUDE reports naming product code ITH, 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 | 2 | — | 0 | 2 |
| 2008 | 4 | 132 | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Hang Ups InvertAlign is intended to be used for inversion, a method of gravity-assisted traction that utilizes the user’s own body weight. Inversion is indicated to: incrcase intervertebral dimentions, decrease pressure on the intervetebral discs, stretch and relax muscles, and temporarily relieve back pain associated with the listed conditions.
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/K991835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991835: Hang Ups Power II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991835
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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