ISOTRON 220
FDA 510(k) clearance K900823 · decided 1990-03-26
Clearance details
- K-number
- K900823
- Device name
- ISOTRON 220
- Applicant
- Excel Tech. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-20
- Decision date
- 1990-03-26
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- IPF
- Device class
- 2
- Regulation number
- 890.5850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Oakville,Ontario, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Excel Tech.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Apollo Quattro (APQ-10M) (K253542) | Weero Co., Ltd. | 2026-06-08 |
| High Tone Power therapy (HiToP) (Model: HiToP PNP) (K252816) | Mohammadali Nezakati | 2026-06-02 |
| StimelMD (SSMD) system (K260142) | Motion Informatics ltd. | 2026-05-27 |
| Compact II (K251083) | Enraf-Nonius, B.V. | 2025-09-12 |
| EVE Synergy (EVE-20M) (K241433) | Weero Co., Ltd. | 2025-06-04 |
| TrainFES Advance (K241488) | Trainfes | 2025-02-05 |
| Quantum Mitohormesis (QMT) (M2101) (K240348) | Quantumtx Pte. , Ltd. | 2024-12-19 |
| eMVFit (MVF-10M) (K240992) | Weero Co., Ltd. | 2024-10-10 |
| BTL-899MS (K240234) | BTL Industries, Inc. | 2024-08-17 |
| MYOTouch Muscle Stimulator (K233098) | Sunmed, LLC | 2024-08-02 |
| Stimulation System (PA series, PR series, S series and Q series) (K232786) | Edan Instruments, Inc. | 2024-05-16 |
| accufit (K233926) | Mettler Electronics Corporation | 2024-03-21 |
Recalls involving this device
No recalls on record reference this clearance.