Setma, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Setma, Inc. makes
Setma, Inc. manufactures mobility and hygiene aids for clinical and long-term care settings, including adjustable-height transfer chairs, burn baths, and trolleys for transporting patients. Their product line also includes specialized bath models, such as the Hygia Bath (Model ST 7200) and variable-height transfer (VHT) and fixed-height transfer (FHT) chairs (Model ST 8130). Shower trolleys are designed to assist patients during bathing procedures.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in the United States, where compliance with U.S. medical device regulations applies. No additional international registries are referenced in the available data.
Catalogue
Variable Height Transfer Chair Ref K841398
Regimes: 510(k) Registry: 510(k)Burn Bath Ref K841397
Regimes: 510(k) Registry: 510(k)Transfer Trolley Ref K841396
Regimes: 510(k) Registry: 510(k)Setma Hygia Bath Model St 7200 Ref K854861
Regimes: 510(k) Registry: 510(k)Setma Vht Ref K853163
Regimes: 510(k) Registry: 510(k)Setma Fht, Model St 8130 Ref K854263
Regimes: 510(k) Registry: 510(k)Shower Trolley Ref K841395
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Setma, Inc. have in the registry?
The registry currently lists 7 devices for Setma, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Setma, Inc.'s devices?
Among its 7 most recently registered devices, Setma, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Setma, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Setma, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Setma, Inc. in the registry?
The most recently registered devices listed for Setma, Inc. include VARIABLE HEIGHT TRANSFER CHAIR, BURN BATH, TRANSFER TROLLEY and SETMA HYGIA BATH MODEL ST 7200.