Chad Therapeutics, Inc.
Chatsworth, CA, US
Chad Therapeutics, Inc. appears in FDA device records in Chatsworth, CA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Chad Therapeutics, Inc. between 1983 and 2008. The busiest year on record is 1984, with 3. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 2 |
| 1989 | 1 |
| 1997 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2004 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K081176 | FLOCHANNEL | MNR | Substantially Equivalent | |
| K070740 | CHAD THERAPEUTICS BONSAI MODEL 800 | NFB | Substantially Equivalent | |
| K042142 | CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S | NFB | Substantially Equivalent | |
| K033364 | CHAD THERAPEUTICS SAGE | NFB | Substantially Equivalent | |
| K020475 | CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 | NFB | Substantially Equivalent | |
| K013472 | TOTAL O2 | CAW | Substantially Equivalent | |
| K010389 | CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 | NFB | Substantially Equivalent | |
| K003455 | MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 | NFB | Substantially Equivalent | |
| K000890 | CHAD THERAPEUTICS OXYMATIC MODEL 401 | NFB | Substantially Equivalent | |
| K971889 | CHAD TOTAL O2 DELIVERY SYSTEM | CAW | Substantially Equivalent | |
| K884562 | OXYMATIC-24 | NFB | Substantially Equivalent | |
| K854239 | OXYCOIL | BYX | Substantially Equivalent | |
| K852650 | OXYMATICTM ELECTRONIC OXGYEN CONSERVER | NFB | Substantially Equivalent | |
| K842968 | CHAD ADJUSTABLE CANNULA | CAT | Substantially Equivalent | |
| K841901 | OXYMIZER FLOW RESTRICTOR | BYX | Substantially Equivalent | |
| K834588 | OXYMIZER-PENDANT | NFB | Substantially Equivalent | |
| K830009 | OXYMIZER | NFB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1068-05 | Sequoia Oxymatic electronic oxygen conservers. Models OM-302, OM-311 ***and OM-312***. | "Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain