FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MULTI-PURPOSE HEALTH DEVICE
K Number: K093322
·
Decision Aug 5, 2010
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
22
Applicant Total
1
Review Days
286
Basic Information
- Device Name
- MULTI-PURPOSE HEALTH DEVICE
- K Number
- K093322
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- UPC MEDICAL SUPPLIES, INC. DBA UNITED PACIFIC CO.
- Date Received
- October 23, 2009
- Decision Date
- August 5, 2010
- Product Code
- BWK
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| BWK | Stimulator, Electro-Acupuncture | FDA unclassified | Unknown |
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