ORTHOPAK BONE GROWTH STIMULATOR
FDA premarket approval P850022/S012 · decided 1999-07-26
Approval details
- PMA number
- P850022
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORTHOPAK BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1999-07-09
- Decision date
- 1999-07-26
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for addition of a 3x5-inch package insert (to be used as a daily patient reminder of the key elements of OrthoPak unit maintenance) into the case of every shipped OrthoPak(R) unit. Each card contains the following information: Bioelectron, Inc., 800-524-0677 Call this number for batteries, electrodes, questions or billing inquiries. 1) Change battery every morning. 2) Change electrodes every 3-7 days or when they will not stick to your skin. Make sure yoru skin is clean and dry before a
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