Lectec Corp.
Mchenry, IL, US
Lectec Corp. appears in FDA device records in Mchenry, IL. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Lectec Corp. between 1977 and 1996. The busiest year on record is 1984, with 5. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1983 | 1 |
| 1984 | 5 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 4 |
| 1988 | 5 |
| 1989 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 3 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K950943 | ULTRA EASE | IYO | Substantially Equivalent | |
| K925384 | ISOPORE(TM) TAPE, MODIFICATION | KGX | Substantially Equivalent | |
| K930258 | TRACET T-6000 | DRX | Substantially Equivalent | |
| K923558 | ECG ELECTRODE | DRX | Substantially Equivalent | |
| K922959 | ISOPORE TAPE | KGX | Substantially Equivalent | |
| K912450 | TRACETS SME 5000 | DRX | Substantially Equivalent | |
| K904512 | TRACET AG 4000 | DRX | Substantially Equivalent | |
| K893425 | VITATRACE | DRX | Substantially Equivalent | |
| K884108 | MACROPORE MEDICAL/SURGICAL PAPER TAPE | KGX | Substantially Equivalent for Some Indications | |
| K882216 | SYNCOR (R) MODEL S-801 ECG ELECTRODE | DRX | Substantially Equivalent | |
| K881872 | TENS ELECTRODE MODEL 238P | GXY | Substantially Equivalent | |
| K881871 | SPARE MS 700 TENS ELECTRODE | GXY | Substantially Equivalent | |
| K875015 | TRACETS 3000 | DRX | Substantially Equivalent | |
| K872250 | LECTEC STIMULATING ELECTRODE | GXY | Substantially Equivalent | |
| K872012 | LECTEC NON-INVASIVE PACING ELECTRODE | DRO | Substantially Equivalent | |
| K870873 | MD MONITORING/DIAGNOSTIC ELECTRODE | DRX | Substantially Equivalent | |
| K863674 | TRACETS 2000/ELECTRODES | DRX | Substantially Equivalent | |
| K863194 | TENDERM TAPE | Substantially Equivalent | ||
| K862765 | EUROMED S-601 | DRX | Substantially Equivalent | |
| K840445 | SYNKARA | DRX | Substantially Equivalent | |
| K840609 | SKIN TECH. ISOTEX 86L | KGX | Substantially Equivalent | |
| K840448 | MEDICAL ADHESIVE FOAM TAPE | KGX | Substantially Equivalent | |
| K840446 | MEDICAL TAPE | KGX | Substantially Equivalent | |
| K840447 | MICROPOROUS MED. ADHESIVE TAPE | KGX | Substantially Equivalent | |
| K833590 | DRESS, SURGICAL ADHESIVE | KGX | Substantially Equivalent | |
| K830798 | STERILE SURGICAL PAIN RELIEF ELECTRODE | GXY | Substantially Equivalent | |
| K771719 | KARAYA ELECTRODES | GXY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Lectec Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Lectec Corp.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain