510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052625Substantially Equivalent

Bionicare Stimulator System, Model Bio-1000

Bionicare Medical Technologies, Inc., Sparks MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052625 is the FDA 510(k) clearance record for BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000, a class II device, cleared for Bionicare Medical Technologies, Inc. on under FDA product code NYN (Stimulator, Electrical, Transcutaneous, For Arthritis). FDA's definition for product code NYN reads: "Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis)". FDA records list 2 510(k) clearances for Bionicare Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K052625.

Clearance record

Decision date
Received
(73 days to decision)
Product code
NYN Stimulator, Electrical, Transcutaneous, For Arthritis
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Bionicare Medical Technologies, Inc. 47 R Loveton Cir., Sparks MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NYN

Trailing 12 months

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

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