Lumiscope Co., Inc.
East Brunswick, NJ, US
Lumiscope Co., Inc. appears in FDA device records in East Brunswick, NJ. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Lumiscope Co., Inc. between 1988 and 2003. The busiest year on record is 1990, with 4. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 4 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032714 | CARDICARE MODEL MT-301F & MT-301C | FLL | Substantially Equivalent | |
| K954792 | LUMISCOPE MODEL 2018 THERMOMETER | FLL | Substantially Equivalent | |
| K931768 | INTERFERENTIAL CURRENT THERAPY UNIT | LIH | Substantially Equivalent | |
| K925054 | INFRARED LAMP | ILY | Substantially Equivalent | |
| K924081 | LUMISONIC | CAF | Substantially Equivalent | |
| K920099 | GYMMAN | DRT | Substantially Equivalent | |
| K901849 | LUMISCOPE EMS 8000 | IPF | Substantially Equivalent | |
| K901096 | LUMISCOPE ALTERNATING PRESSURE PAD & PUMP | FNM | Substantially Equivalent | |
| K901726 | LUMISCOPE MICRO 100 | GZJ | Substantially Equivalent | |
| K901809 | LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25 | GXY | Substantially Equivalent | |
| K894127 | LUMISCOPE MODEL 1000/APCC MODEL 1000 | GZJ | Substantially Equivalent | |
| K884722 | LUMINEB I | BTI | Substantially Equivalent | |
| K880452 | LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE | GZJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- BTICompressor, Air, Portable
- FLLContinuous Measurement Thermometer
- GXYElectrode, Cutaneous
- LIHInterferential Current Therapy
- ILYLamp, Infrared, Therapeutic Heating
- FNMMattress, Air Flotation, Alternating Pressure
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- CAFNebulizer (Direct Patient Interface)
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain