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
K091045Substantially Equivalent

Smart TENS, Model: D-Bc05t

Body Clock Health Care Ltd, London, England, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K091045 is the FDA 510(k) clearance record for SMART TENS, MODEL: D-BC05T, a class II device, cleared for Body Clock Health Care, Ltd. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list 7 510(k) clearances for Body Clock Health Care, Ltd., from to . As of , FDA records show no recalls naming K091045.

Clearance record

Decision date
Received
(249 days to decision)
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Body Clock Health Care, Ltd. 108 George Ln., London, England, GB
510(k) summary
Statement
Third party review
No

Clearances, product code GZJ

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