FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE
K Number: K880452
·
Decision Mar 24, 1988
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
13
Review Days
51
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE
- K Number
- K880452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Lumiscope Co., Inc.
- Date Received
- February 2, 1988
- Decision Date
- March 24, 1988
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZJ), ordered by most recent decision date.
STIMPOD NMS460 Nerve Stimulator
FDA 510(k)
FDA Class 2
·Neurology
actiTENS mini
FDA 510(k)
FDA Class 2
·Neurology
CP Relief Wand Rx - TENS/NMES
FDA 510(k)
FDA Class 2
·Neurology
Unipro (K-UNIPRO-US)
FDA 510(k)
FDA Class 2
·Neurology
TENSWave
FDA 510(k)
FDA Class 2
·Neurology
Electrical Neuromuscular Stimulator, Cure Trio
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Lumiscope Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032714 | CARDICARE MODEL MT-301F & MT-301C | Oct 22, 2003 | Substantially Equivalent |
| K954792 | LUMISCOPE MODEL 2018 THERMOMETER | Jun 21, 1996 | Substantially Equivalent |
| K931768 | INTERFERENTIAL CURRENT THERAPY UNIT | Feb 23, 1994 | Substantially Equivalent |
| K925054 | INFRARED LAMP | Jun 29, 1993 | Substantially Equivalent |
| K924081 | LUMISONIC | Nov 9, 1992 | Substantially Equivalent |
| K920099 | GYMMAN | Mar 9, 1992 | Substantially Equivalent |
| K901849 | LUMISCOPE EMS 8000 | Aug 24, 1990 | Substantially Equivalent |
| K901096 | LUMISCOPE ALTERNATING PRESSURE PAD & PUMP | Aug 21, 1990 | Substantially Equivalent |
| K901726 | LUMISCOPE MICRO 100 | Aug 14, 1990 | Substantially Equivalent |
| K901809 | LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25 | Jun 18, 1990 | Substantially Equivalent |