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SDOClass II

Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation

21 CFR 890.5851 / Physical Medicine

SDO is the FDA product code for Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation, a class II device type, regulated under 21 CFR 890.5851. FDA's definition for this code reads: "A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SDO
Device name
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
FDA definition
A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit.
Regulation
21 CFR 890.5851
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code SDO

By decision year
4 clearances under product code SDO with a decision year between 2024 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SDO by decision year
YearClearances
20241
20251
20262

Applicants with the most clearances

Product code SDO
Applicants holding the most 510(k) clearances under product code SDO
ApplicantClearances
ONWARD Medical Inc.2
Aneuvo1
Spinex, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code