510(k) Report

510(k) · Cleared

Cleared

Ulticare 2500 Treatment Chair

K791016510(k) TraditionalCleared Jun 27, 197926-day reviewClass I21 CFR 880.6140

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

American Health Care Industries, Inc. · FRK Chair, Examination And Treatment

Cleared on Jun 27, 1979 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 27, 1979
Review
26 days
Class
Class I
Product code
FRK
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K791016Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All FRK devices

FRK Chair, Examination And Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRK

FDA has decided no FRK device since 2007.

Median 510(k) review, days · FRK

Too few FRK 510(k)s in any year since 2007 to give a median.

Recalls per year · FRK

No recall names FRK since 2007.

Adverse event reports per year · FRK

12in 2025

2008: 32010: 2792011: 802012: 262013: 712014: 412015: 292016: 202017: 222018: 192019: 72020: 82021: 42022: 12023: 52024: 52025: 12
2007high 279 (2010) · low 0 (2007)2025

MAUDE reports naming product code FRK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—03
20090—00
20100—0279
20110—080
20120—026
20130—071
20140—041
20150—029
20160—020
20170—022
20180—019
20190—07
20200—08
20210—04
20220—01
20230—05
20240—05
20250—012
20260—0—

Recent decisions in FRK

The FRK category page

  • K896275Jedmed J-II ChairJedmed Instrument Co. · 1989
  • K790955Cover GardFem-Gard, Inc. · 1979
  • K790954Heel GardFem-Gard, Inc. · 1979

https://510kreport.com/device/K791016 · printed Nov 3, 2026

Cite this page

510(k) Report. “K791016: Ulticare 2500 Treatment Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K791016

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026