Apex Medical Digital EMS TS1311, TS1312
FDA 510(k) K021754 · Apex Medical Corp.
510(k) numberK021754
Submission
- Device name
- Apex Medical Digital EMS TS1311, TS1312
- Applicant
- Apex Medical Corp.
Shi-Chih, Taipei Hsien, TW - Received
- May 29, 2002
- Decision date
- June 28, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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Questions and answers
When was Apex Medical Digital EMS TS1311, TS1312 cleared by the FDA?
Apex Medical Digital EMS TS1311, TS1312 (K021754) received a 510(k) decision of Substantially Equivalent on June 28, 2002, 30 days after the submission was received.
What is the product code of K021754?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.