Data / Medical devices / Canada / Meditech International Inc
Meditech International Inc: FDA-registered device maker in Toronto Ontario, Canada, 5 510(k) clearances
Meditech International Inc is registered with the FDA (registration 3003082988) in Toronto Ontario, Canada. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 18, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003082988
- Address
- 411 Horner Ave Unit 1, Toronto Ontario, Canada, M8W 4W3
- Owner or operator
- Meditech International Inc (9053578)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- December 27, 2007
- Registered through
- 2026
- Brand names listed
- BIOFLEX Arthritis System, BIOFLEX DualPort System, BIOFLEX LD-I 75 and LD-I 200 Treatment Heads, BIOFLEX LD-R 100 Treatment Head, BIOFLEX MiniPort Home, BIOFLEX MiniPort Professional, BIOFLEX MultiPort System, BIOFLEX Personal System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2008 | K081355 | BIOFLEX LD-R100 TREATMENT HEAD | ILY | Substantially Equivalent | Meditech International, Inc. | accessdata.fda.gov |
| April 2, 2008 | K072551 | LD-I 75 AND LD-I 200 | NHN | Substantially Equivalent | Meditech International, Inc. | accessdata.fda.gov |
| March 13, 2006 | K051875 | BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS | ILY | Substantially Equivalent | Meditech International, Inc. | accessdata.fda.gov |
| February 24, 2005 | K041885 | BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS | ILY | Substantially Equivalent | Meditech International, Inc. | accessdata.fda.gov |
| April 10, 2003 | K023621 | BIOFLEX PROFESSIONAL THERAPY SYSTEM | ILY | Substantially Equivalent | Meditech International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Powered Laser Surgical Instrument
- All makers of Massager, Therapeutic, Electric
Updated December 18, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.