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
K170926Substantially Equivalent

BrainPulse 1100

Jan Medical, Inc., Mountain View CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170926 is the FDA 510(k) clearance record for BrainPulse 1100, a class II device, cleared for Jan Medical, Inc. on under FDA product code POP (Cranial Motion Measurement Device). FDA's definition for product code POP reads: "A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes". FDA records list 2 510(k) clearances for Jan Medical, Inc., from to . As of , FDA records show no recalls naming K170926.

Clearance record

Decision date
Received
(30 days to decision)
Product code
POP Cranial Motion Measurement Device
Regulation
21 CFR 882.1630
Device class
Class II
Review panel
Neurology
Applicant
Jan Medical, Inc. 110 Pioneer Way, Suite L, Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POP

Trailing 12 months

FDA records hold no clearances under product code POP in the trailing twelve months.

FDA records show no clearances under product code POP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code POP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260