Device Atlas

Heavy Foam Heel & Elbow Protectors

Q: What is the product code of K770223?

The FDA product code is IPM – Cover, Limb, a Class I (low risk) device regulated under 21 CFR 890.3025.

FDA 510(k) K770223 · Robert R. Moore

Substantially Equivalent

510(k) numberK770223

Submission

Device name: Heavy Foam Heel & Elbow Protectors
Applicant: Robert R. Moore
Walker, MI, US
Received: February 3, 1977
Decision date: February 23, 1977
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: IPM – Cover, Limb
Device class: Class I (low risk)
Regulation: 21 CFR 890.3025
Specialty: Physical Medicine

Other 510(k)s with product code IPM

510(k)	Device	Applicant	Decision
K872488	Elasto-Gel Cast & Splint PadsIPM · Traditional	Southwest Technologies, Inc.	09/21/1987SN
K823399	Cover LimbIPM · Traditional	Orthopedic Systems, Inc.	11/29/1982SE
K801627	Cover, LimbIPM · Traditional	The Owenby Co.	07/28/1980SE
K780905	Limb CoverIPM · Traditional	Hydro-Med Products, Inc.	08/14/1978SE
K761114	Foam SlippersIPM · Traditional	Fred Sammons, Inc.	12/02/1976SE

More from Fred Sammons, Inc.

510(k)	Device	Decision
K770658	Exerciser, Leg, Lower ExtremityION · Traditional	06/17/1977SE
K770501	Knee Cuff for Expressing Fluid · Traditional	04/05/1977SE
K770060	X-Ray Positioning DeviceKPR · Traditional	01/24/1977SE
K770059	Orthopedic Specialties · Traditional	01/14/1977SE

Questions and answers

When was Heavy Foam Heel & Elbow Protectors cleared by the FDA?

Heavy Foam Heel & Elbow Protectors (K770223) received a 510(k) decision of Substantially Equivalent on February 23, 1977, 20 days after the submission was received.

What is the product code of K770223?

The FDA product code is IPM – Cover, Limb, a Class I (low risk) device regulated under 21 CFR 890.3025.