510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253638Substantially Equivalent

xStep (xStep)

Spinex, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253638 is the FDA 510(k) clearance record for xStep (xStep), a class II device, cleared for Spinex, Inc. on under FDA product code SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation). FDA's definition for product code SDO 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...". FDA records list one 510(k) clearance for Spinex, Inc. As of , FDA records show no recalls naming K253638.

Clearance record

Decision date
Received
(152 days to decision)
Product code
SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Regulation
21 CFR 890.5851
Device class
Class II
Review panel
Physical Medicine
Applicant
Spinex, Inc. 37917 Lavender Commons, Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SDO

Trailing 12 months
3 clearances under product code SDO in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SDO, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260