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
K905569Substantially Equivalent

Electro-Nerve Stimulator Tens,model Systems Plus/a

BioMedical Life Systems Inc., San Marcos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905569 is the FDA 510(k) clearance record for ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A, a class II device, cleared for Biomedical Life Systems, Inc. on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list 37 510(k) clearances for Biomedical Life Systems, Inc., from to . As of , FDA records show no recalls naming K905569.

Clearance record

Decision date
Received
(197 days to decision)
Product code
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
Biomedical Life Systems, Inc. 1285 Stone Dr. #103, San Marcos CA
Third party review
No

Clearances, product code GZB

Trailing 12 months

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

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