510(k) Report

510(k) · Cleared

Cleared

Arp Pov Sport

K093999510(k) TraditionalCleared Aug 10, 2010225-day reviewClass II21 CFR 890.5850

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

Arp Manufacturing, Inc. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning

Cleared on Aug 10, 2010 as substantially equivalent to K011880 (Compex S.A., 2002) and 2 other predicates after a 225-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.

Decided
Aug 10, 2010
Review
225 days
Class
Class II
Product code
NGX
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K940301 (1994). 6 ancestors in all, the oldest K893851 (1989). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1989: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2019: 1 descendant clearedK940301 · Compex 2 · Biodex Medical Systems, Inc. · 1994K011880 · Compex Sport · Compex S.A. · 2002K060846 · Therapeutic Massage Companion · Endurance Therapeutics · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 1 descendant K060846 · Therapeutic Massage Companion · Endurance Therapeutics · 2007K011880 · Compex Sport · Compex S.A. · 2002K940301 · Compex 2 · Biodex Medical Systems, Inc. · 19940
  1. Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
  2. 2 generations backK011880 Compex SportCompex S.A. · 2002
  3. 1 generation backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
  4. This deviceK093999 Arp Pov SportArp Manufacturing, Inc. · 2010
  5. Descendant · cites it directly · 0 of its ownK191181 NXPRO Neuromuscular Electrical Stimulation DeviceNeux Technologies, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K191181NXPRO Neuromuscular Electrical Stimulation DeviceNeux Technologies, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K940301Compex 2Biodex Medical Systems, Inc.1994—
−2K011880Compex SportCompex S.A.2002—
−1K060846Therapeutic Massage CompanionEndurance Therapeutics2007—
0 (this device)K093999Arp Pov SportArp Manufacturing, Inc.2010—
+1K191181NXPRO Neuromuscular Electrical Stimulation DeviceNeux Technologies, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
200410
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K093999, 1994–2019Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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 NGX? 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 NGX device

  1. #1 K250146 SofWave Systemscore 15.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K011880Compex SportCompex S.A.2002—
*K893851Therastim
Summary page 2
…l Equivalence: The POV Sport Powered Muscle Stimulator is substantially equivalent to the Compex Sport KOI 1880, the TheraStim Muscle Stimulator K893851, and Endurance Therapeutics Model T1040 K060846. The modes, frequency, output, and indicati…
Physiodynamics, Inc.1989—
*K060846Therapeutic Massage Companion
Summary page 2
…stantially equivalent to the Compex Sport KOI 1880, the TheraStim Muscle Stimulator K893851, and Endurance Therapeutics Model T1040 K060846. The modes, frequency, output, and indications for use are substantially equivalent. Test Data: The A…
Endurance Therapeutics2007—

Also cleared against K011880: 11 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K191181NXPRO Neuromuscular Electrical Stimulation DeviceNeux Technologies, Inc.20190

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 16 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K191181 (Neux Technologies, Inc., 2019) has gone furthest, with 0 descendants of its own.
  • 11 other devices also cite its predicate K011880.

How does its category compare?

All NGX devices

NGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · NGX

15in 2025

2007: 72008: 32009: 42010: 62011: 52012: 32013: 62014: 62015: 92016: 42017: 102018: 62019: 142020: 112021: 122022: 62023: 122024: 122025: 152026 (partial year): 4
2007high 15 (2025) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGX

93in 2025

2007: 135 days median2008: 209 days median2009: 132 days median2010: 180 days median2011: 291 days median2012: 362 days median2013: 269 days median2014: 298 days median2015: 184 days median2016: 240 days median2017: 108 days median2018: 104 days median2019: 167 days median2020: 207 days median2021: 256 days median2022: 307 days median2023: 96 days median2024: 207 days median2025: 93 days median2026 (partial year): 118 days median
2007high 362 (2012) · low 93 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NGX

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NGX

15in 2025

2011: 12013: 12015: 72016: 212017: 22018: 62019: 42020: 72021: 52022: 72023: 82024: 112025: 15
2007high 21 (2016) · low 0 (2007)2025

MAUDE reports naming product code NGX, 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
2007713500
2008320900
2009413200
2010618000
2011529101
2012336200
2013626921
2014629800
2015918407
20164240021
20171010802
2018610406
20191416704
20201120707
20211225605
2022630707
2023129608
202412207011
20251593015
202641180—

What is it indicated for?

The ARP POV Sport is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ARP POV Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The AR-P POV Sport is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated. The POV Sport's electrical impulses allow triggering action potential on…

Read the full statement (171 words)

The ARP POV Sport is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

The ARP POV Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The AR-P POV Sport is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated.

The POV Sport's electrical impulses allow triggering action potential on motoneurones of motornerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the POV Sport can impose on the stimulated muscles are able to improve or facilitate muscle performance.

The ARP POV Sport is considered a technique of muscle training.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K093999: Arp Pov Sport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093999

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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