Schuldt Laboratories, Inc.
CanadaFDA applicant, unverified
- Devices
- 2
What Schuldt Laboratories, Inc. makes
Schuldt Laboratories, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices, including single-channel and dual-channel models designed for pain management. The SCHULDT* PLUS 8 and SCHULDT* PC* devices deliver controlled electrical stimulation to alleviate acute or chronic pain through skin electrodes.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company’s products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance standards.
Catalogue
Schuldt* Plus 8 T.E.N.S. Device Ref K864368
Regimes: 510(k) Registry: 510(k)Schuldt* Pc* - Dual Channel Tens Ref K880980
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Schuldt Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Schuldt Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Schuldt Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Schuldt Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Schuldt Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Schuldt Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Schuldt Laboratories, Inc. in the registry?
The most recently registered devices listed for Schuldt Laboratories, Inc. include SCHULDT* PLUS 8 T.E.N.S. DEVICE and SCHULDT* PC* - DUAL CHANNEL TENS.