510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K970436Substantially Equivalent

E-Reader

Natural Herbal Products, Inc., Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970436 is the FDA 510(k) clearance record for E-READER, a class II device, cleared for Natural Herbal Products, Inc. on under FDA product code GZO (Device, Galvanic Skin Response Measurement). FDA records list one 510(k) clearance for Natural Herbal Products, Inc. As of , FDA records show no recalls naming K970436.

Clearance record

Decision date
Received
(191 days to decision)
Product code
GZO Device, Galvanic Skin Response Measurement
Regulation
21 CFR 882.1540
Device class
Class II
Review panel
Neurology
Applicant
Natural Herbal Products, Inc. 724 Wiggins Bay Dr., Naples FL
510(k) summary
Statement
Third party review
No

Clearances, product code GZO

Trailing 12 months

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

FDA records show no clearances under product code GZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZO, 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