510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K233631Substantially Equivalent

ZapStim Controller Application (Z1023)

Revital Lab, Inc., Los Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233631 is the FDA 510(k) clearance record for ZapStim Controller Application (Z1023), a class II device, cleared for Revital Lab, Inc. on under FDA product code OBP (Transcranial Magnetic Stimulator). FDA's definition for product code OBP reads: "A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the...". FDA records list one 510(k) clearance for Revital Lab, Inc. As of , FDA records show no recalls naming K233631.

Clearance record

Decision date
Received
(88 days to decision)
Product code
OBP Transcranial Magnetic Stimulator
Regulation
21 CFR 882.5805
Device class
Class II
Review panel
Neurology
Applicant
Revital Lab, Inc. 2349 Aragon Canyon St., Los Vegas NV
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBP

Trailing 12 months
9 clearances under product code OBP in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OBP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20262
April 20260
May 20262
June 20260
July 20260
August 20262
September 20261
October 20260