510(k) · Cleared

Cleared

Forceguard

K955034510(k) TraditionalCleared Apr 10, 1996160-day reviewClass II21 CFR 890.5575

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

Impact Monitors, Inc. · IRN Device, Warning, Overload, External Limb, Powered

Cleared on Apr 10, 1996 as substantially equivalent to K882974 (Boulder Impact Monitors, Inc., 1988) and 2 other predicates after a 160-day review. Its family tree reaches back 1 generation to 1977. 2 later devices descend from it.

Decided: Apr 10, 1996
Review: 160 days
Class: Class II
Product code: IRN
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K770405 (1977). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK770405 Overload Warning DeviceSynthes (Usa) · 1977
This deviceK955034 ForceguardImpact Monitors, Inc. · 1996
Descendant · cites it directly · 1 of its ownK023161 Smartstep SystemAndante Medical Device, Ltd. · 2002
Descendant · 2 generations on · 0 of its ownK060150 Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006

Most influential descendants

Showing 2 of 2 · See all

K023161Smartstep SystemAndante Medical Device, Ltd. · 2002 · cites it directly1descendant
K060150Smartstep System/Smarstep Clinic SystemAndante Medical Devices, Ltd. · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K770405	Overload Warning Device	Synthes (Usa)	1977	—
0 (this device)	K955034	Forceguard	Impact Monitors, Inc.	1996	—
+1	K023161	Smartstep System	Andante Medical Device, Ltd.	2002	—
+2	K060150	Smartstep System/Smarstep Clinic System	Andante Medical Devices, Ltd.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1988	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2006	1	0

FIG. 1 — Lineage of K955034, 1977–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 IRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K882974	Force Guard I Summary page 1 …Trade name: ForceGuard Common name: Overload alarm, Limb load monitor Classification: Alarm, Overload, External Limb, Powered Substantially Equivalent to: Force Guard 1 K882974 Impact Monitors, Inc. Pelimit K770405 Synthes (USA) K792241 Colmed Ltd. Intended Use ForceGuard is used to sense the amount of…	Boulder Impact Monitors, Inc.	1988	—
*	K770405	Overload Warning Device Summary page 1 …verload alarm, Limb load monitor Classification: Alarm, Overload, External Limb, Powered Substantially Equivalent to: Force Guard 1 K882974 Impact Monitors, Inc. Pelimit K770405 Synthes (USA) K792241 Colmed Ltd. Intended Use ForceGuard is used to sense the amount of weight applied to the plantar surface…	Synthes (Usa)	1977	—
*	K792241	Pelimit Summary page 1 …ad monitor Classification: Alarm, Overload, External Limb, Powered Substantially Equivalent to: Force Guard 1 K882974 Impact Monitors, Inc. Pelimit K770405 Synthes (USA) K792241 Colmed Ltd. Intended Use ForceGuard is used to sense the amount of weight applied to the plantar surface of the foot. The devic…	Colmed, Ltd.	1979	—

Also cleared against K882974: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023161	Smartstep System	Andante Medical Device, Ltd.	2002	1

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?

None of the 3 ancestors has a recall.
Of its descendants, K023161 (Andante Medical Device, Ltd., 2002) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K882974.

How does its category compare?

All IRN devices

IRN Device, Warning, Overload, External Limb, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IRN

FDA has decided no IRN device since 2007.

Median 510(k) review, days · IRN

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

Recalls per year · IRN

No recall names IRN since 2007.

Adverse event reports per year · IRN

No MAUDE report names IRN since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

ForceGuard is used to sense the amount of weight applied to the plantar surface of the foot. The device alerts the wearer and/or therapist with a repeating tone when the weight exceeds the pre-selected value.

ForceGuard will be used on patients whe have bore, connective tissue or soft tissue damage who also have been instructed by a physician to limit the weight being placed on a lower limb.

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/K955034 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955034: Forceguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955034

Report an extraction error

Are you the manufacturer?

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