Sport Medical Technology Inc
Shirley, NY, US
Sport Medical Technology Inc appears in FDA device records in Shirley, NY. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Sport Medical Technology Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Biodex Medical Systems, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 9 510(k) clearances for Sport Medical Technology Inc between 1994 and 2009. The busiest year on record is 1994, with 4. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 4 |
| 1995 | 3 |
| 2007 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | KPT | Substantially Equivalent | |
| K063666 | SHARPS CONTAINER, MODEL 039-413 | MMK | Substantially Equivalent | |
| K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | IKK | Substantially Equivalent | |
| K950981 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 | IXR | Substantially Equivalent | |
| K942694 | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 | KHX | Substantially Equivalent | |
| K940301 | COMPEX 2 | IPF | Substantially Equivalent for Some Indications | |
| K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) | BXB | Substantially Equivalent | |
| K935216 | SEMI-RECUMBENT CYCLES | BXB | Substantially Equivalent | |
| K935061 | LOWER BODY CYCLES | BXB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2431314 | 2431314 | Sport Medical Technology Inc | 49 Natcon Drive, Shirley, NY 11967 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2581-2021 | AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332 | When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration | Class II | Terminated | |
| Z-2580-2021 | Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330. | When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain