Scolitron Stimulator
by Ebi, L.P. PMA
Active
PMA P820008
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP820008 | Date12 Sep 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Scolitron(Tm) Stimulator
- Generic Name
- Stimulator, functional neuromuscular, scoliosis
- PMA Number
- FDA Product Code
- LWB
- Device Class
- Class III
- Advisory Committee
- Physical Medicine
- FDA Decision
- APPR Approved
- PMA Supplement
- S003
Overview
AI-generated summary, 18 Sep 2026
The Scolitron Stimulator is a functional neuromuscular stimulator designed for the treatment of scoliosis. It delivers electrical stimulation to modulate muscle activity in support of spinal alignment.
It is supplied as a reusable device intended for clinical use under professional supervision. The device holds FDA PMA authorization (P820008) and is manufactured by Ebi, L.P. in Parsippany, NJ.
Other devices from Ebi, L.P.
Questions
AI-generated answers, 18 Sep 2026
What type of device is the Scolitron Stimulator?
The Scolitron Stimulator is classified as a functional neuromuscular stimulator for scoliosis, as defined in its specifications and authorized under FDA PMA.
Who manufactures the Scolitron Stimulator and where are they located?
The Scolitron Stimulator is manufactured by Ebi, L.P., located at 399 Jefferson Rd., Parsippany, NJ 07054.
What regulatory authorization does the Scolitron Stimulator have?
The Scolitron Stimulator has received FDA Premarket Approval (PMA) under application number P820008, with a decision date of September 12, 1986.