BioMedical Life Systems Inc.
Carlsbad, CA, US
BioMedical Life Systems Inc. appears in FDA device records in Carlsbad, CA. FDA records list 37 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 37 510(k) clearances for BioMedical Life Systems Inc. between 1984 and 2018. The busiest year on record is 2004, with 6. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 3 |
| 1987 | 2 |
| 1989 | 1 |
| 1991 | 5 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 1 |
| 1999 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 6 |
| 2005 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172971 | BMLS16-1 | NUH | Substantially Equivalent | |
| K102051 | PAIN BUDDY | NUH | Substantially Equivalent | |
| K061476 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 | GZJ | Substantially Equivalent | |
| K042711 | MODEL BMLS03-7 | GZJ | Substantially Equivalent | |
| K041388 | COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 | GZJ | Substantially Equivalent | |
| K040007 | INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 | LIH | Substantially Equivalent | |
| K033174 | BMLS03-3 | IPF | Substantially Equivalent | |
| K040824 | INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 | LIH | Substantially Equivalent | |
| K040306 | HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 | IPF | Substantially Equivalent | |
| K033455 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 | GZJ | Substantially Equivalent | |
| K031427 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 | IPF | Substantially Equivalent | |
| K021588 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5 | IPF | Substantially Equivalent | |
| K021271 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 | GZJ | Substantially Equivalent | |
| K021270 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2 | GZJ | Substantially Equivalent | |
| K022925 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 | GZJ | Substantially Equivalent | |
| K022841 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 | GZJ | Substantially Equivalent | |
| K020712 | ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4 | GZJ | Substantially Equivalent | |
| K010749 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL | IPF | Substantially Equivalent | |
| K010209 | ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL | GZJ | Substantially Equivalent | |
| K990230 | ELECTRO-NERVE STIMULATOR TENS, MODEL LX | GZJ | Substantially Equivalent | |
| K932916 | GALVANIC GENERATOR MODEL IMF4150/A | IPF | Substantially Equivalent | |
| K925687 | INTERFERENTIAL STIMULATOR MODEL IMF4150/A | LIH | Substantially Equivalent | |
| K925686 | THERA PULSE A ELECTRO NERVE STIMULATOR | GZJ | Substantially Equivalent | |
| K921441 | INTERFERENTIAL STIMULATOR MODEL INF 4150/A | LIH | Substantially Equivalent | |
| K915210 | ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A | GZJ | Substantially Equivalent | |
| K905569 | ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A | GZB | Substantially Equivalent | |
| K905570 | ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A | GZJ | Substantially Equivalent | |
| K905377 | ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A | GZJ | Substantially Equivalent | |
| K905230 | ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A | GZJ | Substantially Equivalent | |
| K905571 | ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A | LIH | Substantially Equivalent | |
| K884651 | ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000 | IPF | Substantially Equivalent | |
| K871126 | ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C | GZJ | Substantially Equivalent | |
| K871125 | ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN | GZJ | Substantially Equivalent | |
| K851191 | ELECTRO-NERVE STIMULATOR DISCO B9 TENS | GZJ | Substantially Equivalent | |
| K851185 | ELECTRO-NERVE STIMULATOR B4/B400 | GZJ | Substantially Equivalent | |
| K844076 | ELECTRO-NERVE STIMULATOR B5/SK700B | GZJ | Substantially Equivalent | |
| K841184 | ELECTRO-NERVE STIMULATOR HL | GZJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2024292 | 2024292 | BioMedical Life Systems Inc. | 1954 Kellogg Avenue, Carlsbad, CA 92008 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain