Product code NYN— Neurology
BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
- Classification name
- Stimulator, Electrical, Transcutaneous, For Arthritis
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Total cleared
- 8
- First cleared
- Most recent
FDA classification definition
“Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).”
Market context for product code NYN
FDA has cleared devices under product code NYN between 1997 and 2015, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2011
- 2008
- 2007
- 2005
- 2003
- 1999
- 1997
Top applicants under product code NYN
Recent clearances under product code NYN
- K142236 — BioniCare Hand System
- K111557 — X-FORCE
- K073386 — JOINT STIM, MODEL 1000
- K062325 — RS-4I MUSCLE STIMULATOR FAMILY
- K052625 — BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
- K030332 — MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
- K983228 — BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
- K971437 — BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000
Data sourced from openFDA. This site is unofficial and independent of the FDA.