510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021588Substantially Equivalent

Electro Neuromuscular Stimulator, Model Bmls02-5

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

K021588 is the FDA 510(k) clearance record for ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5, a class II device, cleared for Biomedical Life Systems, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 37 510(k) clearances for Biomedical Life Systems, Inc., from to . As of , FDA records show no recalls naming K021588.

Clearance record

Decision date
Received
(275 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Biomedical Life Systems, Inc. P.O. Box 1360, Vista CA
510(k) summary
Statement
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260