510(k) Report

PMA · Approved

Approved

Scolitron (TM) Stimulator

P820008PMAApproved Jan 6, 1983342-day reviewClass III

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

Ebi, L.P. · LWB Stimulator, Functional Neuromuscular, Scoliosis

Approved on Jan 6, 1983 through premarket approval, which rests on the device’s own clinical evidence after a 342-day review.

Decided
Jan 6, 1983
Review
342 days
Class
Class III
Product code
LWB
Recalls
None

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P820008 has 5 supplements since 1983: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

1983: 11986: 21987: 2
1983high 2 (1986) · low 0 (1984)1987
View FIG. 1 as a table
YearSupplements approved
19831
19862
19872
FIG. 1 — Supplements to P820008, 1983–1987Source: FDA PMA database

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

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

Planning a device in LWB? 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
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Does it have a predicate?

PMA decisions do not claim a predicate device.

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 LWB devices

LWB Stimulator, Functional Neuromuscular, Scoliosis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWB

FDA has decided no LWB device since 2007.

Median 510(k) review, days · LWB

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

Recalls per year · LWB

No recall names LWB since 2007.

Adverse event reports per year · LWB

No MAUDE report names LWB since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Ebi, L.P.

101 FDA decisions under this applicant name. See the company

  • K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P. · 2010
  • K100220Polaris Spinal SystemEbi, L.P. · 2010
  • K093880Peanut Growth Control Plating SystemEbi, L.P. · 20101 recall
  • K092574Esl Spinal SystemEbi, L.P. · 2010
  • K093057Biomet Vision Footring SystemEbi, L.P. · 2009

Recent decisions in LWB

The LWB category page

https://510kreport.com/device/P820008 · printed Nov 6, 2026

Cite this page

510(k) Report. “P820008: Scolitron (TM) Stimulator.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P820008

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